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FDA 510(k) Application Details - K081363
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K081363
Device Name
Dressing, Wound, Drug
Applicant
ADVANCED MEDICAL SOLUTIONS LIMITED
ROAD THREE
WINSFORD INDUSTRIAL ESTATE
WINSFORD CHESHIRE CW7 3PD GB
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Contact
CLAIRE RYAN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
05/15/2008
Decision Date
09/24/2008
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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