Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K102494 |
Device Name |
THE BUZZ FACIAL TONING SYSTEM |
Applicant |
DAKA INTERNATIONAL LTD. |
1131 ANTHEM VIEW LANE |
KNOXVILLE,
TN
37922
|
|
Applicant Contact |
BOB WAGNER |
Correspondent |
DAKA INTERNATIONAL LTD. |
1131 ANTHEM VIEW LANE |
KNOXVILLE,
TN
37922
|
|
Correspondent Contact |
BOB WAGNER |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 08/31/2010 |
Decision Date | 12/09/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|