510(k) K953946
K953946 is an FDA 510(k) premarket notification submitted by Nucletron-Oldelft Corp. for the device "MICROSELECTRON-HDR VERSION 2". The FDA issued a decision of Substantially Equivalent on August 13, 1996. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron-Oldelft Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1996
- Date Received
- August 21, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Applicator, Radionuclide, Remote-Controlled
- Device Class
- Class II
- Regulation Number
- 892.5700
- Review Panel
- RA
- Submission Type