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FDA 510(k) Application Details - K090823
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K090823
Device Name
Dressing, Wound, Drug
Applicant
SEWON CELLONTECH CO., LTD.
13340 E. FIRESTONE BLVD.
SUITE J
SANTA FE SPRINGS, CA 90670 US
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Contact
EUGENE BANG
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
03/26/2009
Decision Date
10/22/2009
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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