PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL
FDA 510(k) clearance K850207 · decided 1985-03-01
Clearance details
- K-number
- K850207
- Device name
- PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL
- Applicant
- Syncor Intl. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-18
- Decision date
- 1985-03-01
- Days to decision
- 42 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- 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.