STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER— 510(k) K964216
Substantially EquivalentStarkey Laboratories, Inc.
FDA 510(k) clearance K964216 for STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER, Substantially Equivalent on 1996-12-06. Applicant: Starkey Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Starkey Laboratories, 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
- Eden Prairie, MN, US
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