Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K001723 |
Device Name |
COOL-TEC ELECTRODES |
Applicant |
SEEDLING ENTERPRISES. LLC. |
5 WHITCOMB AVE. |
AYER,
MA
01432
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
SEEDLING ENTERPRISES. LLC. |
5 WHITCOMB AVE. |
AYER,
MA
01432
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/06/2000 |
Decision Date | 07/19/2000 |
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
|