FDA 510(k) Application Details - K050177

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K050177
Device Name Dressing, Wound, Collagen
Applicant COVALON TECHNOLOGIES, INC.
14510 KANDI COURT
LARGO, FL 33774 US
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Contact PAUL L GUILBAUD
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 01/26/2005
Decision Date 04/27/2005
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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