MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS


Device Classification Name

lens, contact (other material) – daily

510(k) Number K103561
Device Name MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Applicant
MENICON CO. LTD.
187 ballardvale street
suite 180
wilmington, 
MA 
01887

Applicant Contact beverley d venuti
Correspondent
MENICON CO. LTD.
187 ballardvale street
suite 180
wilmington, 
MA 
01887

Correspodent Contact beverley d venuti
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 12/06/2010
Decision Date 02/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No