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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.
# 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 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
Predetermined Change
Control Plan Authorized		 No
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