PMA P910074S001

Device: CONTACLAIR MULTI-PURPOSE SOLUTION
Applicant: Eureka Laboratories, Inc.
PMA number: P910074
Supplement: S001
Product code: LPN
Decision date: 1997-07-03
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR EXPANDING THE INDICATIONS TO INCLUDE USE WITH SILICONE/ACRYLATE AND FLUOROSILICONE/ACRYLATE RIGID GAS PERMEABLE (RGP) CONTACT LENSES. WHEN USED WITH RGP LENSES, THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME, CONTACLAIR(R) RGP MULTI-PURPOSE SOLUTION, AND IS INDICATED FOR USE IN CLEANING, RINSING, DISINFECTING AND STORING DAILY AND EXTENDED WEAR RGP CONTACT LENSES.

Current openFDA PMA Record#

Device: CONTACLAIR MULTI-PURPOSE SOLUTION
Applicant: Eureka Laboratories, Inc.
PMA number: P910074
Supplement: S001
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1997-07-03
Decision code: APPR
Date received: 1997-04-18
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR EXPANDING THE INDICATIONS TO INCLUDE USE WITH SILICONE/ACRYLATE AND FLUOROSILICONE/ACRYLATE RIGID GAS PERMEABLE (RGP) CONTACT LENSES. WHEN USED WITH RGP LENSES, THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME, CONTACLAIR(R) RGP MULTI-PURPOSE SOLUTION, AND IS INDICATED FOR USE IN CLEANING, RINSING, DISINFECTING AND STORING DAILY AND EXTENDED WEAR RGP CONTACT LENSES.