SENSATEC ENDOSCOPIC INSTRUMENTS

Electrosurgical, Cutting & Coagulation & Accessories

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Sensatec Endoscopic Instruments.

Pre-market Notification Details

Device IDK942080
510k NumberK942080
Device Name:SENSATEC ENDOSCOPIC INSTRUMENTS
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactCarol A Weideman, Ph.d
CorrespondentCarol A Weideman, Ph.d
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-29
Decision Date1994-11-17

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