STORZ PHACOEMULSIFICATION NEEDLES
FDA 510(k) clearance K946176 · decided 1995-02-14
Clearance details
- K-number
- K946176
- Device name
- STORZ PHACOEMULSIFICATION NEEDLES
- Applicant
- Storz Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-19
- Decision date
- 1995-02-14
- Days to decision
- 57 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 19G Standard 30 Phaco Needle, Model DP8130S, 6 pouches/box. The firm name on recall (Z-1723-2010) | Bausch & Lomb Inc | 2010-05-28 |
| Bausch & Lomb 19G Standard 45 Phaco Needle, Model DP8145S, 6 pouches per box. The firm nam recall (Z-1724-2010) | Bausch & Lomb Inc | 2010-05-28 |