FDA 510(k) Application Details - K050999

Device Classification Name Syringe, Piston

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510(K) Number K050999
Device Name Syringe, Piston
Applicant JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP
SHANJIANG ROAD
NANCHANG, JIANGXI 330204 CN
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Contact YUN YUAN GAO
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 04/20/2005
Decision Date 09/02/2005
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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