FDA 510(k) Application Details - K012124

Device Classification Name Suture, Nonabsorbable, Silk

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510(K) Number K012124
Device Name Suture, Nonabsorbable, Silk
Applicant JOHNSON & JOHNSON MEDICAL (CHINA) LTD.
#75 NAN GU ZHI ROAD
MONHANG, SHANGHAI 200245 CN
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Contact BEN TANG
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Regulation Number 878.5030

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Classification Product Code GAP
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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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