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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, circumcision
510(k) Number K142163
Device Name MALE CIRCUMCISION KITS:RAPIDECLAMP
Applicant
MEDICFIT TECHNOLOGY SDN BHD
55 NORTHERN BLVD
GREAT NECK,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
MEDICFIT TECHNOLOGY SDN BHD
55 NORTHERN BLVD
GREAT NECK,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number884.4530
Classification Product Code
HFX  
Date Received08/06/2014
Decision Date 04/20/2015
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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