510(k) K032372
K032372 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007". The FDA issued a decision of Substantially Equivalent on August 15, 2003. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2003
- Date Received
- August 1, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Applicator, Radionuclide, Remote-Controlled
- Device Class
- Class II
- Regulation Number
- 892.5700
- Review Panel
- RA
- Submission Type