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FDA 510(k) Application Details - K072560
Device Classification Name
Dressing,Wound,Occlusive
More FDA Info for this Device
510(K) Number
K072560
Device Name
Dressing,Wound,Occlusive
Applicant
TEIKOKU PHARMA USA, INC.
1718 RINGWOOD AVE.
SAN JOSE, CA 95131-1711 US
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Contact
MARGIE NEMCIK-CRUZ
Other 510(k) Applications for this Contact
Regulation Number
878.4020
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Classification Product Code
NAD
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More FDA Info for this Product Code
Date Received
09/11/2007
Decision Date
06/17/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K072560
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