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510(k) K091034

AQUACEL AG SURGICAL by Convatec — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2009
Date Received
April 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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