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FDA 510(k) Application Details - K113774
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K113774
Device Name
Dressing, Wound, Drug
Applicant
PRUGEN IP HOLDINGS, INC
8714 E. VISTA
BONITA DR.
SCOTTSDALE, AZ 85255 US
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Contact
SEAN LONERGAN
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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
12/22/2011
Decision Date
02/09/2012
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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