FDA 510(k) Application Details - K140820

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K140820
Device Name Dressing, Wound, Collagen
Applicant VISCUS BIOLOGICS LLC
P.O.BOX 560
STILLWATER, MN 55082 US
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Contact ELAINE DUNCAN
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 04/01/2014
Decision Date 06/26/2015
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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