MEDELA INVIA WOUND THERAPY


Device Classification Name

negative pressure wound therapy powered suction pump

510(k) Number K080357
Device Name MEDELA INVIA WOUND THERAPY
Applicant
MEDELA AG
laettichstrasse 4b
baar, zug, 

CH

ch-6341

Applicant Contact bruno gretler
Correspondent
MEDELA AG
laettichstrasse 4b
baar, zug, 

CH

ch-6341

Correspodent Contact bruno gretler
Regulation Number 878.4780
Classification Product Code
OMP  
Date Received 02/11/2008
Decision Date 07/24/2008
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