PRESSURE SENSING SCOPE SHEATH SYSTEM

Arthroscope

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Pressure Sensing Scope Sheath System.

Pre-market Notification Details

Device IDK944553
510k NumberK944553
Device Name:PRESSURE SENSING SCOPE SHEATH SYSTEM
ClassificationArthroscope
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactCarol A Weideman
CorrespondentCarol A Weideman
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-16
Decision Date1995-09-08

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