CS137 SEALED SOURCES
FDA 510(k) clearance K850434 · decided 1985-03-26
Clearance details
- K-number
- K850434
- Device name
- CS137 SEALED SOURCES
- Applicant
- Syncor Intl. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-04
- Decision date
- 1985-03-26
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- KXK
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sylmar, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.