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FDA 510(k) Application Details - K073614
Device Classification Name
Suture, Surgical, Absorbable, Polydioxanone
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4840
More FDA Info for this Regulation Number
Classification Product Code
NEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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