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FDA 510(k) Application Details - K170270
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K170270
Device Name
Dressing, Wound, Drug
Applicant
LS Scientific Inc. D.B.A. KSE Scientific
2714 South Miami Boulevard
Durham, NC 27703 US
Other 510(k) Applications for this Company
Contact
Jordan Reynolds
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
01/27/2017
Decision Date
06/23/2017
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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