ENVOYCEM, MODEL 1640— 510(k) K080032
Substantially EquivalentEnvoy Medical Corporation
FDA 510(k) clearance K080032 for ENVOYCEM, MODEL 1640, Substantially Equivalent on 2008-02-28. Applicant: Envoy Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Envoy Medical Corporation
- Product code
- Code NEA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code NEA
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