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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 K103830
Device Name JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
Applicant
Jiangsu Shenli Medical Production Factory
15637 Fox Cove Circle
Mosely,  VA  23120
Applicant Contact DARREN REEVES
Correspondent
Jiangsu Shenli Medical Production Factory
15637 Fox Cove Circle
Mosely,  VA  23120
Correspondent Contact DARREN REEVES
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/30/2010
Decision Date 07/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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