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FDA 510(k) Application Details - K113332
Device Classification Name
Lancet, Blood
More FDA Info for this Device
510(K) Number
K113332
Device Name
Lancet, Blood
Applicant
ACON LABORATORIES, INC.
10125 MESA RIM ROAD
SAN DIEGO, CA 92121 US
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Contact
AARON FRIDAY
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
FMK
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More FDA Info for this Product Code
Date Received
11/14/2011
Decision Date
04/18/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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