Device Classification Name |
epilator, high frequency, tweezer-type
|
510(k) Number |
K973340 |
Device Name |
TWEEZER-TYPE EPILATOR |
Applicant |
MOBIT, INC. |
420 LEXINGTON AVE. |
NEW YORK,
NY
10170
|
|
Applicant Contact |
JAMES R MARSHALL |
Correspondent |
MOBIT, INC. |
420 LEXINGTON AVE. |
NEW YORK,
NY
10170
|
|
Correspondent Contact |
JAMES R MARSHALL |
Regulation Number | 878.5360
|
Classification Product Code |
|
Date Received | 09/05/1997 |
Decision Date | 12/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|