510(k) DEN100025
- Device
- WIDEXLINK IN CLEAR SERIES HEARING AIDS
- Applicant
- Office Research IN Clinical Amplifiction
- 510(k) number
- DEN100025
- Product code
- OSM
- Decision
- Unknown (DENG)
- Decision date
- 2011-03-31
- Date received
- 2010-10-13
- Regulation
- 874.3305
- Classification name
- Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- FRANCIS KUK
- Address
- 2300 Cabot Dr., Suite 415 Lisle IL US 60532 60532
FDA Registration Numbers#
- 2430101
- 3011586575
- 3014579188
- 3042472334
- 3010408889
- 3005019184
- 2182204
- 3043173076
- 3015965752
- 3027487235
- 8021514
- 3042957826
- 3005650109
- 3015990335
- 3021334102
- 2183732
- 3015140207
- 3026048380
- 3037001880
- 3023007429
- 3005085999
- 3019414808
- 2240713
- 3010841212
- 3018999226
- 1044692
- 3017995697
- 3004929038
- 3016171795
- 8040564
- 3011927597
- 3003303986
- 3006312495
- 3017441596
- 3017610929
- 3009307953
- 3025427079
- 3030682076
- 2523532
- 3005900820
- 3038593312
- 1450042
- 3017207990
- 3026035667
- 3005465494
- 3012213704
- 3030396448
- 3032954841
- 3006544364
- 3005321947
- 3008848788
- 3010197022
- 3011925220
- 9616024
- 3002808415
- 3036679760
- 3003426343
- 3013294311
- 9611864
- 3002159143
- 2125608
- 3019622583
- 3008606477
- 3030535004
- 3017827954
- 3041897366
- 3008914505
- 3006076696
- 3007694978
- 3019872458
- 3019918054
- 3011350813
- 3036034945
- 3029745674
- 3002686300
Source Documents#
510(k) summary PDF not indicated by FDA