PHACO CHOP NEEDLES
FDA 510(k) clearance K041998 · decided 2004-08-16
Clearance details
- K-number
- K041998
- Device name
- PHACO CHOP NEEDLES
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-26
- Decision date
- 2004-08-16
- Days to decision
- 21 days
- Clearance type
- Special
- 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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