510(k) K982226
K982226 is an FDA 510(k) premarket notification submitted by Uromed Corp. for the device "UROMED BRACHYTHERAPHY IODINE-125 SOURCES". The FDA issued a decision of Substantially Equivalent on May 13, 1999. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Uromed Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1999
- Date Received
- June 24, 1998
- 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