The following data is part of a premarket notification filed by Action Products, Inc. with the FDA for Radiation Bolus.
| Device ID | K811528 |
| 510k Number | K811528 |
| Device Name: | RADIATION BOLUS |
| Classification | System, Therapeutic, X-ray |
| Applicant | ACTION PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-01 |
| Decision Date | 1981-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00089904010728 | K811528 | 000 |
| 00089904000156 | K811528 | 000 |
| 00089904000163 | K811528 | 000 |
| 00089904000170 | K811528 | 000 |
| 00089904000187 | K811528 | 000 |
| 00089904000194 | K811528 | 000 |
| 00089904000224 | K811528 | 000 |
| 00089904000255 | K811528 | 000 |
| 00089904004789 | K811528 | 000 |
| 00089904000149 | K811528 | 000 |
| 00089904000132 | K811528 | 000 |
| 00089904000040 | K811528 | 000 |
| 00089904000064 | K811528 | 000 |
| 00089904000071 | K811528 | 000 |
| 00089904000088 | K811528 | 000 |
| 00089904000095 | K811528 | 000 |
| 00089904000101 | K811528 | 000 |
| 00089904000118 | K811528 | 000 |
| 00089904000125 | K811528 | 000 |
| 00089904004796 | K811528 | 000 |
| 00089904004802 | K811528 | 000 |
| 00089904004819 | K811528 | 000 |
| 00089904009838 | K811528 | 000 |
| 00089904010384 | K811528 | 000 |
| 00089904007810 | K811528 | 000 |
| 00089904007964 | K811528 | 000 |
| 00089904007971 | K811528 | 000 |
| 00089904008077 | K811528 | 000 |
| 00089904008398 | K811528 | 000 |
| 00089904010827 | K811528 | 000 |
| 00089904007537 | K811528 | 000 |
| 00089904006516 | K811528 | 000 |
| 00089904004826 | K811528 | 000 |
| 00089904004864 | K811528 | 000 |
| 00089904004871 | K811528 | 000 |
| 00089904004888 | K811528 | 000 |
| 00089904004895 | K811528 | 000 |
| 00089904004918 | K811528 | 000 |
| 00089904005175 | K811528 | 000 |
| 00089904005526 | K811528 | 000 |
| 00089904111227 | K811528 | 000 |