PHACO TIP
FDA 510(k) clearance K914229 · decided 1991-12-27
Clearance details
- K-number
- K914229
- Device name
- PHACO TIP
- Applicant
- Tri-Star Ophthalmic
- Decision
- Substantially Equivalent
- Date received
- 1991-09-20
- Decision date
- 1991-12-27
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Liberty, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.