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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lancet, blood
510(k) Number K113513
Device Name PLANCET
Original Applicant
MICROPOINT TECHNOLOGIES PTE LTD
11, kallang place
#06-10/12
singapore,  SG 339155
Original Contact chee y lim
Regulation Number878.4800
Classification Product Code
FMK  
Date Received11/28/2011
Decision Date 07/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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