TBA


Device Classification Name

set, administration, intravascular

510(k) Number K121269
Device Name TBA
Applicant
MIGADA PLANT
north industrial zone
kiryat shmona, 

IL

10258

Applicant Contact yossi shachar
Correspondent
MIGADA PLANT
north industrial zone
kiryat shmona, 

IL

10258

Correspodent Contact yossi shachar
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 04/26/2012
Decision Date 01/22/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No