Device Classification Name |
epilator, high frequency, needle-type
|
510(k) Number |
K860056 |
Device Name |
BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) |
Applicant |
BERKOWITS SCHOOL OF ELECTROLYSIS, INC. |
107-25 METROPOLITAN AVE. |
FOREST HILLS,
NY
11375
|
|
Applicant Contact |
BARRY HERMAN |
Correspondent |
BERKOWITS SCHOOL OF ELECTROLYSIS, INC. |
107-25 METROPOLITAN AVE. |
FOREST HILLS,
NY
11375
|
|
Correspondent Contact |
BARRY HERMAN |
Regulation Number | 878.5350
|
Classification Product Code |
|
Date Received | 01/06/1986 |
Decision Date | 02/05/1986 |
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
|