SUR-FIT LOOP OSTOMY O.R. SET

Collector, Ostomy

E. R. SQUIBB & SONS, INC.

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.

Pre-market Notification Details

Device IDK811240
510k NumberK811240
Device Name:SUR-FIT LOOP OSTOMY O.R. SET
ClassificationCollector, Ostomy
Applicant E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York,  NY  10019
Product CodeEXB  
CFR Regulation Number876.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-04
Decision Date1981-06-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10768455116017 K811240 000
10768455116000 K811240 000

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