FDA 510(k) Application Details - K042102

Device Classification Name Syringe, Antistick

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510(K) Number K042102
Device Name Syringe, Antistick
Applicant JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP
SHAN JIANG ZHEN ROAD
NAN CHANG, JIANGXI 330204 CN
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Contact LIU KUN SHENG
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 08/04/2004
Decision Date 03/08/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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