CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K024045
Device Name CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
Original Applicant
CONTAMAC LTD.
623 glacier dr.
grand junction, 
CO 
81503

Original Contact martin dalsing
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 12/06/2002
Decision Date 02/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No