OPTHALMIC ENDOSCOPE
FDA 510(k) clearance K832405 · decided 1983-11-21
Clearance details
- K-number
- K832405
- Device name
- OPTHALMIC ENDOSCOPE
- Applicant
- Cilco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-07-21
- Decision date
- 1983-11-21
- Days to decision
- 123 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING (P820016/S002) | Cilco, Inc. | 1991-12-20 |