GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K024003
Device Name GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT
Original Applicant
GELFLEX
three hutton st.
osborne park
perth, 

AU

6017

Original Contact peter g bryant
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 12/04/2002
Decision Date 02/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No