STERIDYNE STERILE PRESERVED SALINE SOLUTION
FDA premarket approval P870007/S001 · decided 1988-07-19
Approval details
- PMA number
- P870007
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STERIDYNE STERILE PRESERVED SALINE SOLUTION
- Generic name
- Accessories, soft lens products
- Applicant
- Optopics Laboratories Corp.
- Date received
- 1988-01-27
- Decision date
- 1988-07-19
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairton, NJ
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 |
|---|---|---|
| WETTING SOLUTION FOR HARD CONTACT LENSES (K914483) | Optopics Laboratories Corp. | 1992-02-05 |