MEDPOR OCULAR CONFORMER
FDA 510(k) clearance K972034 · decided 1998-01-20
Clearance details
- K-number
- K972034
- Device name
- MEDPOR OCULAR CONFORMER
- Applicant
- Porex Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-02
- Decision date
- 1998-01-20
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- HQN
- Device class
- 2
- Regulation number
- 886.3130
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fairburn, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OCULAR CONFORMER (K970319) | Xavier A. Guerra, Ocularist, Inc. | 1997-07-07 |
| OCULAR CONFORMER (K970318) | Southwest Artificial Eyes, Inc. | 1997-07-07 |
| KOLBERG OPHTHALMIC CONFORMER (K945110) | Kolberg Ocular Products, Inc. | 1995-01-13 |
| STERILE/SINGLE USE SYMBLEPHARON RING (K921221) | Storz Instrument Co. | 1992-07-17 |
| STERILE/SINGLE USE OPHTHALMIC CONFORMERS (K921229) | Storz Instrument Co. | 1992-06-09 |
| MOLDEYE (K772168) | Robert B. Scott Ocularists of Florida, Inc. | 1977-11-30 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The device recall (Z-2302-2008) | Porex Surgical, Inc. | 2008-09-20 |