I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
FDA 510(k) clearance K904612 · decided 1990-12-26
Clearance details
- K-number
- K904612
- Device name
- I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
- Applicant
- Medical Technical Products
- Decision
- Substantially Equivalent
- Date received
- 1990-10-11
- Decision date
- 1990-12-26
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Laguna Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.