MENICON Z RIGID GAS PERMEABLE CONTACT LENS


Device Classification Name

lens, contact (other material) – daily

510(k) Number K081443
Device Name MENICON Z RIGID GAS PERMEABLE CONTACT LENS
Applicant
MENICON CO. LTD.
269a ballardvale st.
wilmington, 
MA 
01887

Applicant Contact beverley d venuti
Correspondent
MENICON CO. LTD.
269a ballardvale st.
wilmington, 
MA 
01887

Correspodent Contact beverley d venuti
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 05/22/2008
Decision Date 09/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No