MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM
FDA 510(k) clearance K837030 · decided 1983-01-24
Clearance details
- K-number
- K837030
- Device name
- MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM
- Applicant
- Meditec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-20
- Decision date
- 1983-01-24
- Days to decision
- 35 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.