STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
FDA 510(k) clearance K851936 · decided 1985-08-20
Clearance details
- K-number
- K851936
- Device name
- STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
- Applicant
- Staar Surgical Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-06
- Decision date
- 1985-08-20
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- HQE
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Monrovia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.