E9000 SYSTEM

Arthroscope

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for E9000 System.

Pre-market Notification Details

Device IDK990524
510k NumberK990524
Device Name:E9000 SYSTEM
ClassificationArthroscope
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactLaura Seneff
CorrespondentLaura 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 Received1999-02-19
Decision Date1999-07-15
Summary:summary

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