CONTACLAIR MULTI-PURPOSE SOLUTION
FDA premarket approval P910074/S001 · decided 1997-07-03
Approval details
- PMA number
- P910074
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CONTACLAIR MULTI-PURPOSE SOLUTION
- Generic name
- Accessories, soft lens products
- Applicant
- Eureka Laboratories, Inc.
- Date received
- 1997-04-18
- Decision date
- 1997-07-03
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ESTERASE-CHLOROESTERASE, STAINING KIT (K791092) | Eureka Laboratories, Inc. | 1979-06-12 |