VCARE A


Device Classification Name

negative pressure wound therapy powered suction pump

510(k) Number K121817
Device Name VCARE A
Applicant
IVT MEDICAL LTD
pob 6718
efrat, 

IL

91435

Applicant Contact eli orbach
Correspondent
IVT MEDICAL LTD
pob 6718
efrat, 

IL

91435

Correspodent Contact eli orbach
Regulation Number 878.4780
Classification Product Code
OMP  
Date Received 06/20/2012
Decision Date 09/17/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No