INTEGRE, MODEL LP581


Device Classification Name

laser, ophthalmic

510(k) Number K080423
Device Name INTEGRE, MODEL LP581
Applicant
Ellex Medical Pty. Ltd.
82 gilbert st.
adelaide, south australia, 

AU

5000

Applicant Contact kevin howard
Correspondent
Ellex Medical Pty. Ltd.
82 gilbert st.
adelaide, south australia, 

AU

5000

Correspodent Contact kevin howard
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 02/15/2008
Decision Date 03/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No