MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
FDA 510(k) clearance K033941 · decided 2004-02-10
Clearance details
- K-number
- K033941
- Device name
- MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-19
- Decision date
- 2004-02-10
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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