The following data is part of a premarket notification filed by Izi Medical Products Llc with the FDA for Cushioncast Moldable Cushions.
| Device ID | K162265 |
| 510k Number | K162265 |
| Device Name: | CushionCast Moldable Cushions |
| Classification | Accelerator, Linear, Medical |
| Applicant | IZI Medical Products LLC 5 Easter Court Suite J Owings Mills, MD 21117 |
| Contact | Qiang Cao |
| Correspondent | Qiang Cao IZI Medical Products LLC 5 Easter Court Suite J Owings Mills, MD 21117 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-11 |
| Decision Date | 2016-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815212022951 | K162265 | 000 |