SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K011089
Device Name SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C
Original Applicant
SPECIALTY ULTRAVISION, INC.
307 orchard city dr.
suite 100
campbell, 
CA 
95008

Original Contact debbie mcintire
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 04/10/2001
Decision Date 05/23/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No