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FDA 510(k) Application Details - K082089
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K082089
Device Name
Dressing, Wound, Drug
Applicant
PRUGEN, INC.
10 SOUTH LASALLE STREET
SUITE 3300
CHICAGO, IL 60603 US
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Contact
ROBERT L KNECHTEL
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Regulation Number
000.0000
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Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
07/24/2008
Decision Date
01/13/2009
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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