AC WOUND TREATMENT SYSTEM


Device Classification Name

negative pressure wound therapy powered suction pump

510(k) Number K111949
Device Name AC WOUND TREATMENT SYSTEM
Applicant
NANO VIBRONIX, INC.
1468 harwell ave
crofton, 
MD 
21114

Applicant Contact e j smith
Correspondent
NANO VIBRONIX, INC.
1468 harwell ave
crofton, 
MD 
21114

Correspodent Contact e j smith
Regulation Number 878.4780
Classification Product Code
OMP  
Date Received 07/08/2011
Decision Date 06/29/2012
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