SOUNDCHOICE BTE— 510(k) K921122
Substantially EquivalentBausch & Lomb, Inc.
FDA 510(k) clearance K921122 for SOUNDCHOICE BTE, Substantially Equivalent on 1992-03-30. Applicant: Bausch & Lomb, Inc.. Device class: 1.
Clearance details
- Applicant
- Bausch & Lomb, Inc.
- 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
- Eden Prairie, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.