NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K023791
Device Name NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
Original Applicant
SOFTFOCAL COMPANY, INC.
69 sullivan dr.
moraga, 
CA 
94556

Original Contact robert b mandell
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 11/13/2002
Decision Date 01/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No