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FDA 510(k) Application Details - K131848
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K131848
Device Name
Dressing, Wound, Drug
Applicant
PURICORE INC.
508 LAPP RD.
MALVERN, PA 19355 US
Other 510(k) Applications for this Company
Contact
ART MORSE
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
06/21/2013
Decision Date
03/31/2014
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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