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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 K103510
Device Name UNIMAX SPECIMEN RETRIEVAL SYSTEM
Applicant
Unimax Medical Systems, Inc.
# 45, Minshen Rd.
Danshui Town
Taipei County,  TW 251
Applicant Contact MICHAEL LEE
Correspondent
Unimax Medical Systems, Inc.
# 45, Minshen Rd.
Danshui Town
Taipei County,  TW 251
Correspondent Contact MICHAEL LEE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/29/2010
Decision Date 05/06/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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