The following data is part of a premarket notification filed by E. R. Squibb & Sons, Inc. with the FDA for Sur-fit Irrigation Sleeve.
| Device ID | K811160 |
| 510k Number | K811160 |
| Device Name: | SUR-FIT IRRIGATION SLEEVE |
| Classification | Irrigator, Ostomy |
| Applicant | E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York, NY 10019 |
| Product Code | EXD |
| CFR Regulation Number | 876.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-28 |
| Decision Date | 1981-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455104017 | K811160 | 000 |
| 00768455104000 | K811160 | 000 |