The following data is part of a premarket notification filed by Radiation Products Design, Inc. with the FDA for Myvacet 5-07, 7-00 And 9-40.
| Device ID | K791178 |
| 510k Number | K791178 |
| Device Name: | MYVACET 5-07, 7-00 AND 9-40 |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | RADIATION PRODUCTS DESIGN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-25 |
| Decision Date | 1979-09-17 |