510(k) K002446
K002446 is an FDA 510(k) premarket notification submitted by Sun Nuclear Corp. for the device "RE-ENTRANT CHAMBER, MODEL 1008 OR 44D". The FDA issued a decision of Substantially Equivalent on October 23, 2000. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Sun Nuclear Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2000
- Date Received
- August 9, 2000
- 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