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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K113332
Device Name ON CALL CHOSEN LANCING DEVICE
Applicant
ACON LABORATORIES, INC.
10125 MESA RIM ROAD
SAN DIEGO,  CA  92121
Applicant Contact AARON FRIDAY
Correspondent
ACON LABORATORIES, INC.
10125 MESA RIM ROAD
SAN DIEGO,  CA  92121
Correspondent Contact AARON FRIDAY
Regulation Number878.4850
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
Predetermined Change
Control Plan Authorized		 No
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