RADIAL ARTERY COMPRESSION TOURNIQUET


Device Classification Name

clamp, vascular

510(k) Number K111837
Device Name RADIAL ARTERY COMPRESSION TOURNIQUET
Applicant
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
no. 37 chaoqian road
beijing, changping district, 

CN

102200

Applicant Contact shan zhao
Correspondent
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
no. 37 chaoqian road
beijing, changping district, 

CN

102200

Correspodent Contact shan zhao
Regulation Number 870.4450
Classification Product Code
DXC  
Date Received 06/29/2011
Decision Date 09/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No