EASY EYES (TM)
FDA premarket approval P830009/S008 · decided 1988-03-23
Approval details
- PMA number
- P830009
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EASY EYES (TM)
- Generic name
- Accessories, soft lens products
- Applicant
- Eaton Medical Corp.
- Date received
- 1987-10-21
- Decision date
- 1988-03-23
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Memphis, TN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SPIRIT SHIELD (K931718) | Eaton Medical Corp. | 1993-09-20 |
| THE CLEANER ACCESSORY (K921882) | Eaton Medical Corp. | 1992-08-25 |
| EASY EYES TM CONTACT LENS CLEANING MACHINE (K904824) | Eaton Medical Corp. | 1991-07-05 |
| EASY EYES TM LENS CARRYING CASE (K871741) | Eaton Medical Corp. | 1987-07-22 |
| EASY EYES TM LENS CARRYING CASE (K841881) | Eaton Medical Corp. | 1984-12-03 |