Reza Band, Reflux Band— 510(k) K173934
Substantially EquivalentSomna Therapeutics, LLC
FDA 510(k) clearance K173934 for Reza Band, Reflux Band, Substantially Equivalent on 2018-04-13. Applicant: Somna Therapeutics, LLC. Device class: 2.
Clearance details
- Applicant
- Somna Therapeutics, LLC
- Product code
- Code PKA
- Device class
- Class 2
- Regulation
- 21 CFR 874.5900
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Germantown, WI, US
Recent devices under product code PKA
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