NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM


Device Classification Name

negative pressure wound therapy powered suction pump

510(k) Number K080275
Device Name NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Applicant
IASIS MEDICAL, INC.
6393 oakgreen avenue
hastings, 
MN 
55033

Applicant Contact john buan
Correspondent
IASIS MEDICAL, INC.
6393 oakgreen avenue
hastings, 
MN 
55033

Correspodent Contact john buan
Regulation Number 878.4780
Classification Product Code
OMP  
Date Received 02/01/2008
Decision Date 10/09/2008
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