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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 K110004
Device Name ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
Applicant
Advanced Surgical Concepts
355 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
Advanced Surgical Concepts
355 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN KAHAN
Regulation Number876.1500
Classification Product Code
OTJ  
Subsequent Product Code
GCJ  
Date Received01/03/2011
Decision Date 01/26/2011
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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