MAGNETIC RETRIEVER

Laparoscope, General & Plastic Surgery

COOK UROLOGICAL, INC.

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

Pre-market Notification Details

Device IDK925565
510k NumberK925565
Device Name:MAGNETIC RETRIEVER
ClassificationLaparoscope, General & Plastic Surgery
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
ContactMichelle Young
CorrespondentMichelle Young
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-03
Decision Date1993-02-23

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