510(k) K993552
K993552 is an FDA 510(k) premarket notification submitted by Bebig Isotopentechnik GmbH for the device "ISOSEED PD-103". The FDA issued a decision of Substantially Equivalent on March 31, 2000. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2000
- Date Received
- October 20, 1999
- 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