HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR


Device Classification Name

lens, contact (other material) – daily

510(k) Number K021977
Device Name HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
Original Applicant
CONTAMAC LTD.
13 red fox ln.
littleton, 
CO 
80127

Original Contact kevin walls
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 06/17/2002
Decision Date 09/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No