OPTHALAS PHOTOCOAGULATOR
FDA 510(k) clearance K828585 · decided 1983-01-03
Clearance details
- K-number
- K828585
- Device name
- OPTHALAS PHOTOCOAGULATOR
- Applicant
- Synemed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-23
- Decision date
- 1983-01-03
- Days to decision
- 41 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Benicia, CA, 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 |
|---|---|---|
| PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER (P830080) | Synemed, Inc. | 1987-02-17 |