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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 K112358
Device Name UNIMAX TROCAR SYSTEM
Applicant
UNIMAX MEDICAL SYSTEMS, INC.
NO. 45, MINSHEN RD.
DANSHUI TOWN
TAIPEI COUNTY,  TW 251
Applicant Contact MICHAEL LEE
Correspondent
UNIMAX MEDICAL SYSTEMS, INC.
NO. 45, MINSHEN RD.
DANSHUI TOWN
TAIPEI COUNTY,  TW 251
Correspondent Contact MICHAEL LEE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/16/2011
Decision Date 10/17/2011
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
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