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 |