Device Classification Name |
Stimulator, Nerve
|
510(k) Number |
K092292 |
Device Name |
CHECKPOINT |
Applicant |
NDI MEDICAL LLC |
22901 MILLCREEK BOULEVARD |
SUITE 110 |
CLEVELAND,
OH
44122
|
|
Applicant Contact |
JULIE GRILL |
Correspondent |
NDI MEDICAL LLC |
22901 MILLCREEK BOULEVARD |
SUITE 110 |
CLEVELAND,
OH
44122
|
|
Correspondent Contact |
JULIE GRILL |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 07/29/2009 |
Decision Date | 10/28/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|