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FDA 510(k) Application Details - K063190
Device Classification Name
More FDA Info for this Device
510(K) Number
K063190
Device Name
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
Applicant
NOBLE FIBER TECHNOLOGIES, INC.
300 PALM ST.
SCRANTON, PA 18505 US
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Contact
PATRICIA DAVIDSON
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/2006
Decision Date
08/21/2007
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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