510(k) K090366
K090366 is an FDA 510(k) premarket notification submitted by Source Production & Equipment Co., Inc. for the device "SPEC MODEL M-31". The FDA issued a decision of Substantially Equivalent on April 22, 2009. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Source Production & Equipment Co., Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2009
- Date Received
- February 13, 2009
- 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