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FDA 510(k) Application Details - K130040
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K130040
Device Name
Dressing, Wound, Drug
Applicant
MOLNLYCKE HEALTH CARE
5550 PEACHTREE PARKWAY
SUITE 500
NORCROSS, GA 30092 US
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Contact
ANGELA L BUNN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/07/2013
Decision Date
02/12/2014
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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