510(k) K162265
K162265 is an FDA 510(k) premarket notification submitted by Izi Medical Products, LLC for the device "CushionCast Moldable Cushions". The FDA issued a decision of Substantially Equivalent on November 15, 2016. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Izi Medical Products, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2016
- Date Received
- August 11, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type