WETTING SOLUTION FOR HARD CONTACT LENSES
FDA 510(k) clearance K914483 · decided 1992-02-05
Clearance details
- K-number
- K914483
- Device name
- WETTING SOLUTION FOR HARD CONTACT LENSES
- Applicant
- Optopics Laboratories Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-08
- Decision date
- 1992-02-05
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fairton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SORBIC ACID PRESERVED SALINE SOL.PH CHANGE (P870007/S011) | Optopics Laboratories Corp. | 1996-11-13 |
| SORBIC ACID PRESERVED SALINE SOL.PH CHANGE (P870007/S010) | Optopics Laboratories Corp. | 1996-04-22 |
| SORBIC ACID PRESERVED SALINE SOL.PH CHANGE (P870007/S009) | Optopics Laboratories Corp. | 1995-09-20 |
| SORBIC ACID PRESERVED SALINE SOL.PH CHANGE (P870007/S006) | Optopics Laboratories Corp. | 1993-04-14 |
| SORBIC ACID PRESERVED SALINE SOL.PH CHANGE (P870007/S005) | Optopics Laboratories Corp. | 1992-02-25 |
| SORBIC ACID PRESERVED SALINE SOLUTION (P870007/S003) | Optopics Laboratories Corp. | 1990-06-07 |
| STERIDYNE DYNASPRAY (P860050/S007) | Optopics Laboratories Corp. | 1990-05-31 |
| STERIDYNE DYNASPRAY (P860050/S006) | Optopics Laboratories Corp. | 1989-01-05 |