FDA 510(k) Application Details - K110386

Device Classification Name

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510(K) Number K110386
Device Name CELOX RAPID GAUZE
Applicant MEDTRADE PRODUCTS LTD.
ELECTRA HOUSE
CREWE BUSINESS PARK
CREWE, CHESHIRE CW1 6GL CW1 6GL GB
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Contact JONATHAN RANFIELD
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Regulation Number

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Classification Product Code QSY
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Date Received 02/10/2011
Decision Date 05/10/2011
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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