FDA 510(k) Application Details - K051955

Device Classification Name

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510(K) Number K051955
Device Name QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
Applicant Z-MEDICA CORPORATION
4 FAIRFIELD BLVD.
WALLINGFORD, CT 06492 US
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Contact ROBERT V PACKARD
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Regulation Number

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Classification Product Code QSY
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Date Received 07/19/2005
Decision Date 08/10/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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