The following data is part of a premarket notification filed by Southeastern Radiation Products, Inc. with the FDA for .decimal Tissue Compensator/intensity Modulator.
| Device ID | K040804 |
| 510k Number | K040804 |
| Device Name: | .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | SOUTHEASTERN RADIATION PRODUCTS, INC. 2651 N. DESIGN COURT Sanford, FL 32773 |
| Contact | Richard Sweat |
| Correspondent | Richard Sweat SOUTHEASTERN RADIATION PRODUCTS, INC. 2651 N. DESIGN COURT Sanford, FL 32773 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851147007052 | K040804 | 000 |