CushionCast Moldable Cushions
FDA 510(k) K162265 · Izi Medical Products, LLC
510(k) numberK162265
Submission
- Device name
- CushionCast Moldable Cushions
- Applicant
- Izi Medical Products, LLC
Owings Mills, MD, US - Received
- August 11, 2016
- Decision date
- November 15, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was CushionCast Moldable Cushions cleared by the FDA?
CushionCast Moldable Cushions (K162265) received a 510(k) decision of Substantially Equivalent on November 15, 2016, 96 days after the submission was received.
What is the product code of K162265?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.