FDA 510(k) Application Details - K060804

Device Classification Name Dressing, Wound, Drug

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510(K) Number K060804
Device Name Dressing, Wound, Drug
Applicant COVALON TECHNOLOGIES LTD.
2033 IVERSON LANES
WAXHAW, NC 28173 US
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Contact JACQUES LEMMETTI
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 03/24/2006
Decision Date 04/18/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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