ERBE ERBEJET 2 SYSTEM


Device Classification Name

lavage, jet

510(k) Number K072404
Device Name ERBE ERBEJET 2 SYSTEM
Applicant
ERBE USA, INC.
2225 northwest pkwy.
marietta, 
GA 
30067

Applicant Contact john tartal
Correspondent
ERBE USA, INC.
2225 northwest pkwy.
marietta, 
GA 
30067

Correspodent Contact john tartal
Regulation Number 880.5475
Classification Product Code
FQH  
Date Received 08/27/2007
Decision Date 10/31/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No