HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS
FDA premarket approval P890044/S014 · decided 1991-07-08
Approval details
- PMA number
- P890044
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Rand Scientific Corp.
- Date received
- 1991-05-24
- Decision date
- 1991-07-08
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Sacramento, CA
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 |
|---|---|---|
| RAND NASAL PACKING (K963856) | Rand Scientific Corp. | 1996-10-18 |
| SPIRIT RIDGE SILICONE CARVING BLOCK (K961081) | Rand Scientific Corp. | 1996-05-22 |
| DURALASTIC SHEETING II (K961057) | Rand Scientific Corp. | 1996-05-16 |
| PMMA CLASIC (K955777) | Rand Scientific Corp. | 1996-05-16 |
| THE MAGNUM CHIN IMPLANT (K961071) | Rand Scientific Corp. | 1996-04-19 |
| PEC IMPLANT (K961072) | Rand Scientific Corp. | 1996-04-19 |
| MEDIAL MALAR IMPLANT (K961080) | Rand Scientific Corp. | 1996-04-19 |
| THE NAUTILUS (K961124) | Rand Scientific Corp. | 1996-04-19 |