SHAVER ABLATOR

Arthroscope

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Shaver Ablator.

Pre-market Notification Details

Device IDK002088
510k NumberK002088
Device Name:SHAVER ABLATOR
ClassificationArthroscope
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactLaura D Seneff
CorrespondentLaura D Seneff
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 Received2000-07-11
Decision Date2001-03-06

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