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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 K020915
Device Name SOPRO LIGHT SOURCES AND ACCESSORIES
Applicant
SOPRO
PLACE ST. CHRISTOPHE
LES ACCATES-LA VALENTINE
MARSEILLE,  FR F-13011
Applicant Contact PIERRE MONTILLOT
Correspondent
SOPRO
PLACE ST. CHRISTOPHE
LES ACCATES-LA VALENTINE
MARSEILLE,  FR F-13011
Correspondent Contact PIERRE MONTILLOT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/21/2002
Decision Date 06/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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