Device Classification Name |
Epilator, High Frequency, Needle-Type
|
510(k) Number |
K831048 |
Device Name |
TUFCOTE EPILATION PROBE |
Applicant |
SERAPIS MEDICAL ELECTRONICS, CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SERAPIS MEDICAL ELECTRONICS, CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.5350
|
Classification Product Code |
|
Date Received | 03/31/1983 |
Decision Date | 08/12/1983 |
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
|
|
|