FDA 510(k) Application Details - K080097

Device Classification Name

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510(K) Number K080097
Device Name MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET
Applicant MEDTRADE PRODUCTS LTD.
ELECTRA HOUSE
CREWE BUSINESS PARK
CREWE, CHESHIRE CW1 6GL GB
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Contact JONATHAN D RANFIELD
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Regulation Number

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Classification Product Code QSY
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Date Received 01/14/2008
Decision Date 07/09/2008
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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