ELDER PSORALITE SERIES 2000 UVA IRRADIATION SYSTEM
FDA 510(k) clearance K837106 · decided 1983-03-22
Clearance details
- K-number
- K837106
- Device name
- ELDER PSORALITE SERIES 2000 UVA IRRADIATION SYSTEM
- Applicant
- Elder Pharmaceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-10
- Decision date
- 1983-03-22
- Days to decision
- 71 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Bryan, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.