MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER

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 Murdoch Intraoperative Laparoscopic Lens Cleaner.

Pre-market Notification Details

Device IDK935754
510k NumberK935754
Device Name:MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER
ClassificationLaparoscope, General & Plastic Surgery
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer,  IN  47460
ContactRick Lynkins
CorrespondentRick Lynkins
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer,  IN  47460
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-26
Decision Date1994-05-02

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