OMS SILICONE OIL INJECTOR
FDA 510(k) clearance K844895 · decided 1985-06-24
Clearance details
- K-number
- K844895
- Device name
- OMS SILICONE OIL INJECTOR
- Applicant
- Optical Micro Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-17
- Decision date
- 1985-06-24
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- LWL
- Device class
- 3
- Regulation number
- 886.4275
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.