APEX TUBING SET

Arthroscope

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Apex Tubing Set.

Pre-market Notification Details

Device IDK954440
510k NumberK954440
Device Name:APEX TUBING SET
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 Received1995-09-25
Decision Date1995-11-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.