CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE


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

Correspodent Contact rongshan li
Regulation Number 880.5860
Classification Product Code
FMF  
Subsequent Product Codes
FMI   KNW  
Date Received 01/14/2011
Decision Date 04/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No