The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Sur-fit Flexible.
| Device ID | K830945 | 
| 510k Number | K830945 | 
| Device Name: | SUR-FIT FLEXIBLE | 
| Classification | Collector, Ostomy | 
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | EXB | 
| CFR Regulation Number | 876.5900 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1983-03-24 | 
| Decision Date | 1983-04-12 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SUR-FIT FLEXIBLE  73473325  1353891 Live/Registered | E.R. SQUIBB & SONS, INC. 1984-04-02 |