ZYOPTIX XP EPI SEPARATOR SYSTEM
FDA 510(k) clearance K062465 · decided 2006-09-06
Clearance details
- K-number
- K062465
- Device name
- ZYOPTIX XP EPI SEPARATOR SYSTEM
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-24
- Decision date
- 2006-09-06
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- HNO
- Device class
- 1
- Regulation number
- 886.4370
- 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 Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reord recall (Z-1021-2007) | Bausch & Lomb Inc | 2007-08-02 |
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