3 FRENCH FLEXIBLE BIOPSY FORCEPS

Endoscopic Grasping/cutting Instrument, Non-powered

COOK UROLOGICAL, INC.

The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for 3 French Flexible Biopsy Forceps.

Pre-market Notification Details

Device IDK881399
510k NumberK881399
Device Name:3 FRENCH FLEXIBLE BIOPSY FORCEPS
ClassificationEndoscopic Grasping/cutting Instrument, Non-powered
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
ContactFrederick D Roemer
CorrespondentFrederick D Roemer
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
Product CodeOCZ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-04
Decision Date1988-04-11

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