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FDA 510(k) Application Details - K070309
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K070309
Device Name
Dressing, Wound, Drug
Applicant
QUINNOVA PHARMACEUTICALS
301SOUTH STATE STREET
SUITE NOO1
NEWTOWN, PA 18940 US
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Contact
JEFFREY DAY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
02/01/2007
Decision Date
09/12/2008
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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