510(k) K030180
- Device
- CRESCENT TINNITUS RETAINING SOUND GENERATOR
- Applicant
- Starkey Laboratories, Inc.
- 510(k) number
- K030180
- Product code
- KLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-17
- Date received
- 2003-01-17
- Regulation
- 874.3400
- Classification name
- Masker, Tinnitus
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- SCOTT LAPOINTE
- Address
- 6700 Washington Ave. S. Eden Prairie MN US 55344 55344
FDA Registration Numbers
- 2430101
- 3020981894
- 3005019184
- 2182204
- 3027487235
- 8021514
- 3042957826
- 3005650109
- 3005085999
- 2240713
- 3004929038
- 3011927597
- 3003303986
- 3006312495
- 3017441596
- 3009307953
- 3021916254
- 3038593312
- 3005465494
- 3006544364
- 3008848788
- 3010197022
- 3002808415
- 2125608
- 3036679760
- 3003426343
- 3013294311
- 3002159143
- 3019622583
- 3020982310
- 3026390997
- 3002686300
Source Documents
510(k) summary PDF not indicated by FDA
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