LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT

Laparoscope, General & Plastic Surgery

GABRIS SURGICAL CORP.

The following data is part of a premarket notification filed by Gabris Surgical Corp. with the FDA for Laparoscopic/endoscopic Instrument.

Pre-market Notification Details

Device IDK944103
510k NumberK944103
Device Name:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
ClassificationLaparoscope, General & Plastic Surgery
Applicant GABRIS SURGICAL CORP. 1432 NORTH GREAT NECK RD., SUITE 204 Virginia Beach,  VA  23454
ContactKen Beltran
CorrespondentKen Beltran
GABRIS SURGICAL CORP. 1432 NORTH GREAT NECK RD., SUITE 204 Virginia Beach,  VA  23454
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-23
Decision Date1994-09-12

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