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510(k) K022584

CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING by Cardiotech Intl. — Product Code MGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2002
Date Received
August 5, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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