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FDA 510(k) Application Details - K080010
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K080010
Device Name
Dressing, Wound, Drug
Applicant
KYTOGENICS, INC
466 SOUTHERN BLVD.
ADAMS BUILDING, FIRST FLOOR
CHATHAM, NJ 07928 US
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Contact
MARINA ZAZANIS
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
01/03/2008
Decision Date
03/14/2008
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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