ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301


Device Classification Name

injector and syringe, angiographic

510(k) Number K072696
Device Name ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
Applicant
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
suite 8d, zhongxin zhongshan
no.19, lane 999 zhongshan no.2
shanghai, 

CN

200030

Applicant Contact diana hong
Correspondent
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
suite 8d, zhongxin zhongshan
no.19, lane 999 zhongshan no.2
shanghai, 

CN

200030

Correspodent Contact diana hong
Regulation Number 870.1650
Classification Product Code
DXT  
Date Received 09/24/2007
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No