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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 K062968
Device Name LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES
Applicant
MEDSYS, S.A.
13723 DANA LN. EAST
PUYALLUP,  WA  98373
Applicant Contact JEFF MORGAN
Correspondent
MEDSYS, S.A.
13723 DANA LN. EAST
PUYALLUP,  WA  98373
Correspondent Contact JEFF MORGAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/29/2006
Decision Date 01/03/2007
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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