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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K170030
Device Name NOVATECH TALCAIR
Applicant
NOVATECH S.A.
Z.I. ATHELIA III - 1058, VOIE ANTIOPE
LA CIOTAT CEDEX,  FR 13705
Applicant Contact JENNIFER NEFF
Correspondent
BOSTON MEDICAL PRODUCTS INC.
70 CHESTNUT STREET
SHREWSBURY,  MA  01545
Correspondent Contact STUART K. MONTGOMERY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/04/2017
Decision Date 03/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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