Device Classification Name |
Epilator, High Frequency, Needle-Type
|
510(k) Number |
K883892 |
Device Name |
BALLET STERILE DISPOSABLE ELECTROLYSIS |
Applicant |
SYNOPTIC PRODUCTS |
316 HARVARD ST. |
BROOKLINE,
MA
02146
|
|
Applicant Contact |
JAMES PAISNER |
Correspondent |
SYNOPTIC PRODUCTS |
316 HARVARD ST. |
BROOKLINE,
MA
02146
|
|
Correspondent Contact |
JAMES PAISNER |
Regulation Number | 878.5350
|
Classification Product Code |
|
Date Received | 09/14/1988 |
Decision Date | 10/20/1988 |
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
|