RIGID GAS PERMEABLE CONTACT LENS SOLUTION
FDA 510(k) clearance K983836 · decided 1999-02-11
Clearance details
- K-number
- K983836
- Device name
- RIGID GAS PERMEABLE CONTACT LENS SOLUTION
- Applicant
- Polymer Technology Div. Wilmington Partners, L.P.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-30
- Decision date
- 1999-02-11
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- MRC
- Device class
- 2
- Regulation number
- 886.5918
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, recall (Z-0553-2010) | Bausch & Lomb Inc | 2009-12-22 |
| Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Con recall (Z-1735-2009) | Bausch & Lomb Inc | 2009-08-13 |