Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K072260 |
Device Name |
NUFACE, MODEL NU-4003 |
Applicant |
Carol Cole Company |
3366 N. TORREY PINES CT. |
SUITE 130 |
LA JOLLA,
CA
92037
|
|
Applicant Contact |
HOWARD ASHER |
Correspondent |
Carol Cole Company |
3366 N. TORREY PINES CT. |
SUITE 130 |
LA JOLLA,
CA
92037
|
|
Correspondent Contact |
HOWARD ASHER |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 08/14/2007 |
Decision Date | 11/27/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|