POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K080794
Device Name POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Applicant
POLYVUE DISTRIBUTION, INC.
7077 mcadams lane
felton, 
CA 
95018

Applicant Contact garold l edwards
Correspondent
POLYVUE DISTRIBUTION, INC.
7077 mcadams lane
felton, 
CA 
95018

Correspodent Contact garold l edwards
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 03/20/2008
Decision Date 12/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No