FDA 510(k) Application Details - K061722

Device Classification Name

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510(K) Number K061722
Device Name BLOXX RAPID CLOTTING AGENT
Applicant CROSSLINK-D, INC
150 ARAN HILL RD
FARFIELD, CT 06824 US
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Contact LOUIS J MAZZARESE
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Regulation Number

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Classification Product Code QSY
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Date Received 06/19/2006
Decision Date 08/02/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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