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FDA 510(k) Application Details - K100029
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K100029
Device Name
Dressing, Wound, Drug
Applicant
MOLNLYCKE HEALTH CARE
5550 PEACHTREE PARKWAY
SUITE 500
NORCROSS, GA 30092 US
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Contact
STEVEN DOWDLEY
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
01/06/2010
Decision Date
09/15/2010
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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