The following data is part of a premarket notification filed by E. R. Squibb & Sons, Inc. with the FDA for Sur-fit Loop Ostomy O.r. Set.
| Device ID | K811240 |
| 510k Number | K811240 |
| Device Name: | SUR-FIT LOOP OSTOMY O.R. SET |
| Classification | Collector, Ostomy |
| Applicant | E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York, NY 10019 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-04 |
| Decision Date | 1981-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10768455116017 | K811240 | 000 |
| 10768455116000 | K811240 | 000 |