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FDA 510(k) Application Details - K041665
Device Classification Name
Lancet, Blood
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510(K) Number
K041665
Device Name
Lancet, Blood
Applicant
PELIKAN TECHNOLOGIES, INC
1072 EAST MEADOW CIRCLE
PALO ALTO, CA 94303 US
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Contact
JACK S GREEN
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
06/18/2004
Decision Date
07/23/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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