FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
FDA 510(k) clearance K984143 · decided 1999-02-16
Clearance details
- K-number
- K984143
- Device name
- FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
- Applicant
- Fibra Sonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-18
- Decision date
- 1999-02-16
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.