MICROPULSE PHACOEMULSIFICATION SYSTEM
FDA 510(k) clearance K051186 · decided 2005-08-18
Clearance details
- K-number
- K051186
- Device name
- MICROPULSE PHACOEMULSIFICATION SYSTEM
- Applicant
- Trillium Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-09
- Decision date
- 2005-08-18
- Days to decision
- 101 days
- Clearance type
- Abbreviated
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Poulsbo, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.