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FDA 510(k) Application Details - K961085
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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510(K) Number
K961085
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
200 DEBUSK LN.
POWELL, TN 37849 US
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DEBRA F MANNING
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Regulation Number
000.0000
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Classification Product Code
MGQ
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More FDA Info for this Product Code
Date Received
03/19/1996
Decision Date
05/21/1996
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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