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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 K151548
Device Name VersaOne Bladed Trocar, VersaOne Bladeless Trocar
60 Middletown Avenue
North Haven,  CT  06473
Applicant Contact Trang Huynh
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Trang Huynh
Regulation Number876.1500
Classification Product Code
Date Received06/09/2015
Decision Date 07/02/2015
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