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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 K113332
Device Name ON CALL CHOSEN LANCING DEVICE
Original Applicant
ACON LABORATORIES, INC.
10125 mesa rim road
san diego,  CA  92121
Original Contact aaron friday
Regulation Number878.4800
Classification Product Code
FMK  
Subsequent Product Code
NBW  
Date Received11/14/2011
Decision Date 04/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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