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FDA 510(k) Application Details - K132343
Device Classification Name
Dressing, Wound, Collagen
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510(K) Number
K132343
Device Name
Dressing, Wound, Collagen
Applicant
KERECIS LIMITED
EYRARGATA 2
ISAFIJORDUR 400 IS
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Contact
GUDMUNDUR F SIGURJONSSON
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Regulation Number
000.0000
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Classification Product Code
KGN
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More FDA Info for this Product Code
Date Received
07/30/2013
Decision Date
10/23/2013
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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