510(k) K040804
K040804 is an FDA 510(k) premarket notification submitted by Southeastern Radiation Products, Inc. for the device ".DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR". The FDA issued a decision of Substantially Equivalent on April 28, 2004. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. Southeastern Radiation Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2004
- Date Received
- March 29, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Beam-Shaping, Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5710
- Review Panel
- RA
- Submission Type