IRRISEPT WOUND CLEANSING SYSTEM


Device Classification Name

lavage, jet

510(k) Number K080779
Device Name IRRISEPT WOUND CLEANSING SYSTEM
Applicant
IRRIMAX CORPORATION
111 laurel ridge drive
alpharetta, 
GA 
30004

Applicant Contact julie stephens
Correspondent
IRRIMAX CORPORATION
111 laurel ridge drive
alpharetta, 
GA 
30004

Correspodent Contact julie stephens
Regulation Number 880.5475
Classification Product Code
FQH  
Subsequent Product Code
FRO  
Date Received 03/19/2008
Decision Date 02/04/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes