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
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Regulation Number 878.4800

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Classification Product Code FMK
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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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