FILTECH TECHNETIUM-99MM RADIOPHARMACEU
FDA 510(k) clearance K833686 · decided 1984-02-28
Clearance details
- K-number
- K833686
- Device name
- FILTECH TECHNETIUM-99MM RADIOPHARMACEU
- Applicant
- Summa Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-31
- Decision date
- 1984-02-28
- Days to decision
- 120 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.