Nutrifill
FDA 510(k) clearance K181566 · decided 2018-10-22
Clearance details
- K-number
- K181566
- Device name
- Nutrifill
- Applicant
- Contamac, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-14
- Decision date
- 2018-10-22
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- MRC
- Device class
- 2
- Regulation number
- 886.5918
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Saffron Walden, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution recall (Z-1956-2025) | Contamac Solutions, Inc. | 2025-06-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IGEL 67 CONTACT LENS (P860009/S002) | Contamac, Ltd. | 1989-05-09 |
| IDEL 67 CONTACT LENS (P860009/S001) | Contamac, Ltd. | 1987-10-13 |