FDA 510(k) Application Details - K073614

Device Classification Name Suture, Surgical, Absorbable, Polydioxanone

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510(K) Number K073614
Device Name Suture, Surgical, Absorbable, Polydioxanone
Applicant FOOSIN MEDICAL SUPPLIES INC.
SUITE 8D, ZHONGXIN ZHONGSHAN
MANSION, NO. 19 LANE 999
ZHONG SHAN, SHANGHAI 20030 CN
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Contact Diana Hong
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Regulation Number 878.4840

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Classification Product Code NEW
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Date Received 12/26/2007
Decision Date 04/30/2008
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



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