PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM


Device Classification Name

negative pressure wound therapy powered suction pump

510(k) Number K112458
Device Name PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Applicant
MEDICA-RENTS CO., LTD.
p.o. box 205
derby, 
CT 
06418

Applicant Contact dina l weissman, j.d.
Correspondent
MEDICA-RENTS CO., LTD.
p.o. box 205
derby, 
CT 
06418

Correspodent Contact dina l weissman, j.d.
Regulation Number 878.4780
Classification Product Code
OMP  
Date Received 08/26/2011
Decision Date 01/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No