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FDA 510(k) Application Details - K022584
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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510(K) Number
K022584
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
CARDIOTECH INTL.
12106 WEST 75TH LN.
ARVADA, CO 80005-5306 US
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Contact
ANDREW M REED
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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
08/05/2002
Decision Date
12/30/2002
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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