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FDA 510(k) Application Details - K112580
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K112580
Device Name
Dressing, Wound, Collagen
Applicant
DALIM TISSEN CO., LTD.
325 N PUENTE STREET
UNIT B
BREA, CA 92821 US
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Contact
APRIL LEE
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
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More FDA Info for this Product Code
Date Received
09/06/2011
Decision Date
06/01/2012
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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