S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-


the company

Device Classification Name

lenses, soft contact, daily wear

510(k) Number K002099
Device Name S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-
Original Applicant
BESCON CO., LTD.
623 glacier dr.
grand junction, 
CO 
81503

Original Contact martin dalsing
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 07/11/2000
Decision Date 07/09/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls