O-PERM 30
FDA 510(k) clearance K002703 · decided 2000-11-21
Clearance details
- K-number
- K002703
- Device name
- O-PERM 30
- Applicant
- Optical Polymer Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-30
- Decision date
- 2000-11-21
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Gainesville, FL, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| O-PERM F60 RGP CONTACT LENS (P890046/S026) | Optical Polymer Research, Inc. | 1994-03-01 |
| O-PERM F60 RGP CONTACT LENS (P890046/S027) | Optical Polymer Research, Inc. | 1994-03-01 |
| O-PERM F60 RGP CONTACT LENS (P890046/S025) | Optical Polymer Research, Inc. | 1994-01-13 |
| O-PERM F60 RGP CONTACT LENS (P890046/S024) | Optical Polymer Research, Inc. | 1993-11-04 |
| O-PERM F60 RGP CONTACT LENS (P890046/S023) | Optical Polymer Research, Inc. | 1993-09-30 |
| O-PERM F60 RGP CONTACT LENS (P890046/S021) | Optical Polymer Research, Inc. | 1993-09-20 |
| O-PERM F60 RGP CONTACT LENS ADD FINISH LABS (P890046/S020) | Optical Polymer Research, Inc. | 1993-09-20 |
| O-PERM F60 RGP CONTACT LENS (P890046/S022) | Optical Polymer Research, Inc. | 1993-09-20 |