SUR-FIT IRRIGATION SLEEVE

Irrigator, 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 Irrigation Sleeve.

Pre-market Notification Details

Device IDK811160
510k NumberK811160
Device Name:SUR-FIT IRRIGATION SLEEVE
ClassificationIrrigator, Ostomy
Applicant E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York,  NY  10019
Product CodeEXD  
CFR Regulation Number876.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-28
Decision Date1981-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00768455104017 K811160 000
00768455104000 K811160 000

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