PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B


Device Classification Name

sleeve, limb, compressible

510(k) Number K121962
Device Name PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
Applicant
MEGO AFEK AC LTD
kibbutz afek
afek, 

IL

30042

Applicant Contact alex rapel
Correspondent
MEGO AFEK AC LTD
kibbutz afek
afek, 

IL

30042

Correspodent Contact alex rapel
Regulation Number 870.5800
Classification Product Code
JOW  
Date Received 07/05/2012
Decision Date 10/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No