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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name insufflator, laparoscopic
510(k) Number K111441
Device Name UNIMAX VERESS NEEDLE
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 Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
FHO  
Date Received05/24/2011
Decision Date 08/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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