IRRIGATION SYSTEM

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

LINVATEC CORP.

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

Pre-market Notification Details

Device IDK961192
510k NumberK961192
Device Name:IRRIGATION SYSTEM
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactCarol A Weiderman
CorrespondentCarol A Weiderman
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-26
Decision Date1996-04-26

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