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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K050999
Device Name YI XIN STERILE SYRINGE FOR SINGLE USE
Applicant
JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP
SHANJIANG ROAD
NANCHANG, JIANGXI,  CN 330204
Applicant Contact YUN YUAN GAO
Correspondent
JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP
SHANJIANG ROAD
NANCHANG, JIANGXI,  CN 330204
Correspondent Contact YUN YUAN GAO
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received04/20/2005
Decision Date 09/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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