REPROCESSED PHACOEMUISIFICATION TIPS


Device Classification Name

needle, phacoemulsification, reprocessed

510(k) Number K050518
Device Name REPROCESSED PHACOEMUISIFICATION TIPS
Applicant
ALLIANCE MEDICAL, INC.
10232 south 51 st.
phoenix, 
AZ 
85044

Applicant Contact elizabeth renken
Correspondent
ALLIANCE MEDICAL, INC.
10232 south 51 st.
phoenix, 
AZ 
85044

Correspodent Contact elizabeth renken
Regulation Number 886.4670
Classification Product Code
NKX  
Date Received 03/01/2005
Decision Date 09/23/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No