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FDA 510(k) Application Details - K961766
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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510(K) Number
K961766
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
RENAISSANCE PHARMACEUTICAL, INC.
P.O. BOX 216
GLENBROOK, NV 89413 US
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Contact
DARLENE TAYLOR-MCCORD
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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
05/03/1996
Decision Date
07/15/1996
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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