RADIATION BOLUS
FDA 510(k) clearance K811528 · decided 1981-07-10
Clearance details
- K-number
- K811528
- Device name
- RADIATION BOLUS
- Applicant
- Action Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-01
- Decision date
- 1981-07-10
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polym recall (Z-2236-2009) | Action Products Incorporated | 2009-09-22 |
| Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polym recall (Z-2237-2009) | Action Products Incorporated | 2009-09-22 |