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FDA 510(k) Application Details - K041342
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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510(K) Number
K041342
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
STIEFEL LABORATORIES, INC.
ROUTE 145
OAK HILL, NY 12460 US
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Contact
MARY JANE CARR
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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
05/20/2004
Decision Date
07/19/2005
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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