510(k) K850433
K850433 is an FDA 510(k) premarket notification submitted by Syncor Intl. Corp. for the device "CESIUM 137 ENDOMETRIAL SOURCE". The FDA issued a decision of Substantially Equivalent on August 21, 1985. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Syncor Intl. Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1985
- Date Received
- February 4, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Brachytherapy, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type