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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 K142427
Device Name TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25
Applicant
APPLIED MEDICAL RESOURCES
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact AEREE LEE
Correspondent
APPLIED MEDICAL RESOURCES
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact AEREE LEE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/29/2014
Decision Date 12/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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