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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 K123467
Device Name VS3
Applicant
VISIONSENSE, LTD.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact GERARD J PRUD'HOMME
Correspondent
VISIONSENSE, LTD.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact GERARD J PRUD'HOMME
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/09/2012
Decision Date 04/17/2013
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
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