Device Classification Name |
epilator, high frequency, needle-type
|
510(k) Number |
K952611 |
Device Name |
STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION |
Applicant |
STEREX ELECTROLYSIS INTL., LTD. |
174 KINGS ROAD |
TYSELEY |
BIRMINGHAM,
GB
B11 2AP
|
|
Correspondent |
STEREX ELECTROLYSIS INTL., LTD. |
174 KINGS ROAD |
TYSELEY |
BIRMINGHAM,
GB
B11 2AP
|
|
Regulation Number | 878.5350
|
Classification Product Code |
|
Date Received | 06/07/1995 |
Decision Date | 10/18/1995 |
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
|