Device Classification Name |
epilator, high frequency, tweezer-type
|
510(k) Number |
K952117 |
Device Name |
EPILATOR |
Applicant |
BURKE NEUTECH, INC. |
1765 COMMERCE AVE. NORTH |
ST. PETERSBURG,
FL
33716
|
|
Applicant Contact |
ROBERT E BURKE |
Correspondent |
BURKE NEUTECH, INC. |
1765 COMMERCE AVE. NORTH |
ST. PETERSBURG,
FL
33716
|
|
Correspondent Contact |
ROBERT E BURKE |
Regulation Number | 878.5360
|
Classification Product Code |
|
Date Received | 05/05/1995 |
Decision Date | 10/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|