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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 K073170
Device Name R-PORT II LAPAROSCOPIC ACCESS DEVICE
Applicant
ADVANCED SURGICAL CONCEPTS
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
ADVANCED SURGICAL CONCEPTS
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/09/2007
Decision Date 12/03/2007
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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