510(k) K080032
K080032 is an FDA 510(k) premarket notification submitted by Envoy Medical Corporation for the device "ENVOYCEM, MODEL 1640". The FDA issued a decision of Substantially Equivalent on February 28, 2008. The device falls under product code NEA (Cement, Ear, Nose And Throat), a Class II device regulated under 21 CFR 872.3275.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2008
- Date Received
- January 7, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Ear, Nose And Throat
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- EN
- Submission Type