VENODYNE V810


Device Classification Name

sleeve, limb, compressible

510(k) Number K110358
Device Name VENODYNE V810
Applicant
MICROTEK MEDICAL, INC.
602 lehmberg rd.
columbus, 
MS 
39702

Applicant Contact tom bonner
Correspondent
MICROTEK MEDICAL, INC.
602 lehmberg rd.
columbus, 
MS 
39702

Correspodent Contact tom bonner
Regulation Number 870.5800
Classification Product Code
JOW  
Date Received 02/07/2011
Decision Date 05/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No