REFUGE SOUND GENERATOR— 510(k) K041302
Substantially EquivalentMicro-Ear Technology, Inc.
FDA 510(k) clearance K041302 for REFUGE SOUND GENERATOR, Substantially Equivalent on 2004-07-01. Applicant: Micro-Ear Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Micro-Ear Technology, Inc.
- Product code
- Code KLW
- Device class
- Class 2
- Regulation
- 21 CFR 874.3400
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code KLW
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