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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 K100959
Device Name SPECIMEN RETRIEVAL SYSTEM
Applicant
APPLIED MEDICAL RESOURCES
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact FRANS VANDENBROEK
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/07/2010
Decision Date 04/22/2010
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
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