PERCUTANEOUS RETRACTOR KIT

Laparoscope, General & Plastic Surgery

APPLIED UROLOGY, INC.

The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Percutaneous Retractor Kit.

Pre-market Notification Details

Device IDK912903
510k NumberK912903
Device Name:PERCUTANEOUS RETRACTOR KIT
ClassificationLaparoscope, General & Plastic Surgery
Applicant APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills,  CA  92653
ContactJo Stegwell
CorrespondentJo Stegwell
APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills,  CA  92653
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-02
Decision Date1991-08-16

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