TECHNICON-38 (POLYMACON) HYDROPHYLIC LENSES
FDA premarket approval P900065/S001 · decided 1991-08-29
Approval details
- PMA number
- P900065
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECHNICON-38 (POLYMACON) HYDROPHYLIC LENSES
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Westcon Contact Lens Co., Inc.
- Date received
- 1991-08-27
- Decision date
- 1991-08-29
- Days to decision
- 2 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Grand Junction, CO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES (K043540) | Westcon Contact Lens Co., Inc. | 2005-02-01 |
| HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES (K031774) | Westcon Contact Lens Co., Inc. | 2004-02-20 |
| HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) (K023530) | Westcon Contact Lens Co., Inc. | 2002-11-26 |
| W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) (K992010) | Westcon Contact Lens Co., Inc. | 1999-06-29 |
| HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN (K963837) | Westcon Contact Lens Co., Inc. | 1996-12-20 |
| HORIZON/WESTHIN 55-G (K962121) | Westcon Contact Lens Co., Inc. | 1996-08-26 |
| W-55 (METHAFILON A) CONTACT LENS (K954524) | Westcon Contact Lens Co., Inc. | 1996-03-28 |
| HORIZON 55 BI-CON TORIC (K950818) | Westcon Contact Lens Co., Inc. | 1995-03-21 |