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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 K991416
Device Name ENDOSCOPIC CAMERA
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY MCNAMARA CULLINANE
Correspondent
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY MCNAMARA CULLINANE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/23/1999
Decision Date 07/20/1999
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
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