IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K021907
Device Name IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Original Applicant
IGEL VISION CARE PTE LTD.
201 king arthur court
tracy, 
CA 
95376

Original Contact debbie mcintire
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 06/10/2002
Decision Date 09/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No