QUALITONE ITE GENESIS— 510(k) K904731
Substantially EquivalentQualitone
FDA 510(k) clearance K904731 for QUALITONE ITE GENESIS, Substantially Equivalent on 1990-12-17. Applicant: Qualitone. Device class: 1.
Clearance details
- Applicant
- Qualitone
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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