SET, ORAL ADMINISTRATION
FDA 510(k) clearance K760251 · decided 1976-09-15
Clearance details
- K-number
- K760251
- Device name
- SET, ORAL ADMINISTRATION
- Applicant
- Cis Radiopharmaceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-07-19
- Decision date
- 1976-09-15
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- LEY
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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.