RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS


Device Classification Name

negative pressure wound therapy powered suction pump

510(k) Number K110647
Device Name RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
Applicant
SMITH & NEPHEW, INC.
970 lake carillon dr.
st. petersburg, 
FL 
33716

Applicant Contact laura reynolds
Correspondent
SMITH & NEPHEW, INC.
970 lake carillon dr.
st. petersburg, 
FL 
33716

Correspodent Contact laura reynolds
Regulation Number 878.4780
Classification Product Code
OMP  
Subsequent Product Code
BTA  
Date Received 03/07/2011
Decision Date 06/22/2011
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

Recalls CDRH Recalls