VASOVASOSTOMY SET

Surgical Instruments, G-u, Manual (and Accessories)

COOK UROLOGICAL, INC.

The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Vasovasostomy Set.

Pre-market Notification Details

Device IDK921546
510k NumberK921546
Device Name:VASOVASOSTOMY SET
ClassificationSurgical Instruments, G-u, Manual (and Accessories)
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
ContactTammy Bacon
CorrespondentTammy Bacon
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
Product CodeKOA  
CFR Regulation Number876.4730 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-01
Decision Date1993-07-02

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