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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 K110112
Device Name CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE
Applicant
Rongshan LI
11 Georgetown Ct.
Basking Ridge,  NJ  07920
Applicant Contact RONGSHAN LI
Correspondent
Rongshan LI
11 Georgetown Ct.
Basking Ridge,  NJ  07920
Correspondent Contact RONGSHAN LI
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Codes
FMI   KNW  
Date Received01/14/2011
Decision Date 04/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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