SOF PRO-CLEAN CONTACT LENS CLEANER
FDA premarket approval P810041/S007 · decided 1990-09-13
Approval details
- PMA number
- P810041
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOF PRO-CLEAN CONTACT LENS CLEANER
- Generic name
- Accessories, soft lens products
- Applicant
- Lobob Laboratories, Inc.
- Date received
- 1990-06-13
- Decision date
- 1990-09-13
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Jose, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND (K014162) | Lobob Laboratories, Inc. | 2002-01-15 |
| OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION (K001964) | Lobob Laboratories, Inc. | 2000-07-18 |
| OPTIMUM WETTING AND REWETTING DROP (K001428) | Lobob Laboratories, Inc. | 2000-05-26 |
| LOBOB UNIVERSAL CONTACT LENS CLEANER (K990044) | Lobob Laboratories, Inc. | 1999-02-11 |