FDA 510(k) Application Details - K002443

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K002443
Device Name Dressing, Wound, Collagen
Applicant OASIS RESEARCH, LLC.
514 S. VERMONT AVE.
GLENDORA, CA 91741 US
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Contact JAMES CHRISTENSEN
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 08/09/2000
Decision Date 10/18/2000
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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