FDA 510(k) Application Details - K962851

Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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510(K) Number K962851
Device Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant ACRYMED, INC.
12232 S.W. GARDEN PL.
PORTLAND, OR 97223 US
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Contact BRUCE GIBBINS
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Regulation Number 000.0000

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Classification Product Code MGQ
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Date Received 07/22/1996
Decision Date 09/06/1996
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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