Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K002714 |
Device Name |
WARTNER WART REMOVAL SYSTEM |
Applicant |
WARTNER MEDICAL PRODUCTS |
25 BELLINI AVE. |
BRAMPTON, ONTARIO,
CA
L6T 3Z8
|
|
Applicant Contact |
JUDY MAGNER |
Correspondent |
WARTNER MEDICAL PRODUCTS |
25 BELLINI AVE. |
BRAMPTON, ONTARIO,
CA
L6T 3Z8
|
|
Correspondent Contact |
JUDY MAGNER |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 08/31/2000 |
Decision Date | 11/28/2000 |
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
|