FDA 510(k) Application Details - K013390

Device Classification Name

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510(K) Number K013390
Device Name QUICKCLOT
Applicant ON SITE GAS SYSTEMS, INC.
35 BUDNEY RD.
NEWINGTON, CT 06111 US
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Contact C. BURTON GULLONG
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Regulation Number

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Classification Product Code QSY
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Date Received 10/15/2001
Decision Date 05/23/2002
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 Y



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