STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
FDA 510(k) clearance K961310 · decided 1996-06-27
Clearance details
- K-number
- K961310
- Device name
- STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
- Applicant
- Storz Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-04
- Decision date
- 1996-06-27
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bausch & Lomb Millennium Microsurgical System. recall (Z-1663-2010) | Bausch & Lomb Inc | 2010-05-26 |