FLEXIBLE BIOPSY CUP FORCEPS

Bronchoscope (flexible Or Rigid)

SURGICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Flexible Biopsy Cup Forceps.

Pre-market Notification Details

Device IDK941158
510k NumberK941158
Device Name:FLEXIBLE BIOPSY CUP FORCEPS
ClassificationBronchoscope (flexible Or Rigid)
Applicant SURGICAL TECHNOLOGIES, INC. 4715 N.W. 157TH ST., SUITE 212 Miami Lakes,  FL  33014
ContactLaszlo Fazekas
CorrespondentLaszlo Fazekas
SURGICAL TECHNOLOGIES, INC. 4715 N.W. 157TH ST., SUITE 212 Miami Lakes,  FL  33014
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-11
Decision Date1994-04-28

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