Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K070250 |
Device Name |
NUTRITONE FACIAL BEAUTY SYSTEM |
Applicant |
ISOMERS LABORATORIES INC. |
11 DELLCASTLE COURT |
MONTGOMERY VILLAGE,,
MD
20886
|
|
Applicant Contact |
ROBERT MAZZAFERRO |
Correspondent |
ISOMERS LABORATORIES INC. |
11 DELLCASTLE COURT |
MONTGOMERY VILLAGE,,
MD
20886
|
|
Correspondent Contact |
ROBERT MAZZAFERRO |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 01/26/2007 |
Decision Date | 09/04/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|