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FDA 510(k) Application Details - K984082
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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510(K) Number
K984082
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
EMOX 911 CC
P.O. BOX 79
SOMERSET WEST 7129 ZA
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Contact
IVOR DUNCAN
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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
11/16/1998
Decision Date
01/28/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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