NOVATECH TALCAIR

Laparoscope, General & Plastic Surgery

NOVATECH S.A.

The following data is part of a premarket notification filed by Novatech S.a. with the FDA for Novatech Talcair.

Pre-market Notification Details

Device IDK170030
510k NumberK170030
Device Name:NOVATECH TALCAIR
ClassificationLaparoscope, General & Plastic Surgery
Applicant NOVATECH S.A. Z.I. ATHELIA III - 1058, VOIE ANTIOPE La Ciotat Cedex,  FR 13705
ContactJennifer Neff
CorrespondentStuart K. Montgomery
BOSTON MEDICAL PRODUCTS INC. 70 CHESTNUT STREET Shrewsbury,  MA  01545
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-04
Decision Date2017-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14063108104783 K170030 000

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