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FDA 510(k) Application Details - K130670
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K130670
Device Name
Dressing, Wound, Drug
Applicant
HYDROFERA, LLC.
322 MAIN ST., SUITE 1101
WILLIMANTIC, CT 06226 US
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Contact
HEATHER S SOMERS
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
03/12/2013
Decision Date
01/02/2014
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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