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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscopic Single Port Access Device
510(k) Number K101794
Device Name ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA
Applicant
Advanced Surgical Concepts
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
Advanced Surgical Concepts
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number876.1500
Classification Product Code
OTJ  
Subsequent Product Code
GCJ  
Date Received06/28/2010
Decision Date 11/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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