ABDOMINAL TOURNIQUET SYSTEM


Device Classification Name

clamp, vascular

510(k) Number K112384
Device Name ABDOMINAL TOURNIQUET SYSTEM
Applicant
COMPRESSION WORKS LLC
15 sargent ave
providence, 
RI 
02906

Applicant Contact ruth forstadt
Correspondent
COMPRESSION WORKS LLC
15 sargent ave
providence, 
RI 
02906

Correspodent Contact ruth forstadt
Regulation Number 870.4450
Classification Product Code
DXC  
Date Received 08/18/2011
Decision Date 10/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No