FDA 510(k) Application Details - K072560

Device Classification Name Dressing,Wound,Occlusive

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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
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Regulation Number 878.4020

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Classification Product Code NAD
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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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