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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 K083638
Device Name FIXATION TROCARS
Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/09/2008
Decision Date 12/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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