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FDA 510(k) Application Details - K982804
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
More FDA Info for this Device
510(K) Number
K982804
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
INNOVATIVE TECHNOLOGIES (US), INC.
581 CONFERENCE PLACE
GOLDEN,, CO 80401 US
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Contact
JULIE CHAFFEE
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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
08/10/1998
Decision Date
12/16/1998
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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