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FDA 510(k) Application Details - K012124
Device Classification Name
Suture, Nonabsorbable, Silk
More FDA Info for this Device
510(K) Number
K012124
Device Name
Suture, Nonabsorbable, Silk
Applicant
JOHNSON & JOHNSON MEDICAL (CHINA) LTD.
#75 NAN GU ZHI ROAD
MONHANG, SHANGHAI 200245 CN
Other 510(k) Applications for this Company
Contact
BEN TANG
Other 510(k) Applications for this Contact
Regulation Number
878.5030
More FDA Info for this Regulation Number
Classification Product Code
GAP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/06/2001
Decision Date
09/19/2001
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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