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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 K070158
Device Name R-PORT LAPAROSCOPIC ACCESS DEVICE
Applicant
Advanced Surgical Concepts
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact TANYA KAVANAGH
Correspondent
Advanced Surgical Concepts
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact TANYA KAVANAGH
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/17/2007
Decision Date 08/23/2007
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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