VESITEC DRILL GUIDE

Staple, Fixation, Bone

VESITEC MEDICAL, INC.

The following data is part of a premarket notification filed by Vesitec Medical, Inc. with the FDA for Vesitec Drill Guide.

Pre-market Notification Details

Device IDK931182
510k NumberK931182
Device Name:VESITEC DRILL GUIDE
ClassificationStaple, Fixation, Bone
Applicant VESITEC MEDICAL, INC. 26072 MERIT CIRCLE SUITE 125 Laguna Hills,  CA  92653
ContactLinda D'abate
CorrespondentLinda D'abate
VESITEC MEDICAL, INC. 26072 MERIT CIRCLE SUITE 125 Laguna Hills,  CA  92653
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-09
Decision Date1993-06-09

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