SILSOFT (ELASTOFILCON A ) CONTACT LENS
FDA premarket approval P800020/S007 · decided 1985-11-05
Approval details
- PMA number
- P800020
- Supplement
- S007
- Trade name
- SILSOFT (ELASTOFILCON A ) CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Date received
- 1985-08-28
- Decision date
- 1985-11-05
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Midland, MI
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SILASTIC INFLATABLE BONE PLUG H.P. (K853186) | Dow Corning Corp. Healthcare Industries Materials | 1985-09-24 |
| WHITESIDE ACRYLIC CEMENT SPACER SLEEVE (K844637) | Dow Corning Corp. Healthcare Industries Materials | 1985-06-19 |
| DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET (K850255) | Dow Corning Corp. Healthcare Industries Materials | 1985-05-01 |
| TF-II HIP PROSTHESIS (K843995) | Dow Corning Corp. Healthcare Industries Materials | 1985-04-23 |
| WHITESIDE ORTHOLOC TOTAL HIP FEMORAL (K842559) | Dow Corning Corp. Healthcare Industries Materials | 1984-12-20 |
| SSA HIP PROSTHESIS (K840357) | Dow Corning Corp. Healthcare Industries Materials | 1984-02-17 |
| METAL-BACKED ACETABULAR CUP (K831479) | Dow Corning Corp. Healthcare Industries Materials | 1983-06-15 |
| SILASTIC VOICE PROSTHESIS (K812864) | Dow Corning Corp. Healthcare Industries Materials | 1981-11-24 |