FDA 510(k) Application Details - K061494

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K061494
Device Name Dressing, Wound, Collagen
Applicant PEGASUS BIOLOGICS, INC.
6 JENNER
SUITE 150
IRVINE, CA 92618 US
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Contact PAMELA MISAJON
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 05/31/2006
Decision Date 09/21/2006
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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