After this (in 93) we repeated the exercise with a more critical operating-room swab construction used in body cavities during surgery. Later still (in 97) the process was repeated this time to clear Tencel for use in an occlusive burn dressing. Both of these gained FDA approval also.
Courtaulds Research's Focus Polymers unit (who were making wound dressings from alginate nonwovens) made, sterilised and packed the swabs for these trials and I think it was Tom Burrow who recommended we used Evan Dick as the consultant to interface with the FDA. Evan was based in St Louis where Bob Feil, Glyn Raven and I visited him in 91 to set things moving. I asked Glyn Raven if he remembered the visit. His recollection follows as a comment. (Click comment below to see it)
FDA 510(k) Application Details - K921227
| Device Classification Name | Gauze, External (With Drug/Biologic/Animal Source Material) More FDA Info for this Device |
| 510(K) Number | K921227 |
| Device Name | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE |
| Applicant | COURTAULDS FIBERS, INC. P.O. BOX 141 AXIS, AL 36505 Other 510(k) Applications for this Company More Company Info and Competitors |
| Contact | ROBERT FEIL Other 510(k) Applications for this Contact |
| Regulation Number | 000.0000 More FDA Info for this Regulation Number |
| Classification Product Code | GER Other 510(k) Applications for this Device More FDA Info for this Product Code |
| Date Received | 03/13/1992 |
| Decision Date | 05/29/1992 |
| Decision | SE - Substantially Equivalent |
| Classification Advisory Committee | SU - General & Plastic Surgery |
| Review Advisory Committee | SU - General & Plastic Surgery |
1 comment:
Calvin How could i forget that night!! Yes of course the business was about getting FDA approval for Tencel in a medical wipe but the hotel incident comes clearer to mind R Feil had noticed a 12 / 15 and 24 year old collection of The Macallan in the bar and we negotiated a half portioin of each for a collective price then spent about 15 mins deciding which way to go We agreed in the end to go youngest first then up to the 24 yr old I've never forgiven Bob for teaching me that 12 year old Macallan tastes like Bells next to a 24 year old ! I think That was also the trip when we visited Phillip Morris to explore the use of fibrillated hydroentangled Tencel in a cigarette filter tip. Again i will never forget the visit Signs everywhere saying PLease Smoke and the official "tasters" taking the biggest drag out of a ciggy that I have ever seen then swirling it around in their mouths like a fine wine - I nearly puked!! I hate cigarette smoke I think the end result was a potential 0.001 cents increase in unit cost which apparently was a killer in the ciggy business so it did not proceed thank God !
Lots more where that came from lets stay in touch
Post a Comment