The following data is part of a premarket notification filed by E. R. Squibb & Sons, Inc. with the FDA for Sur-fit Disposable Convex Insert.
Device ID | K811239 |
510k Number | K811239 |
Device Name: | SUR-FIT DISPOSABLE CONVEX INSERT |
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 | 1981-06-09 |