Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K011708 |
Device Name |
MODIFICATION TO WARTNER WART REMOVAL SYSTEM |
Applicant |
WARTNER MEDICAL PRODUCTS |
25 BELLINI AVE. |
BRAMPTON, ONTARIO,
CA
L6T 3Z8
|
|
Applicant Contact |
NANCY LUM-WILSON |
Correspondent |
WARTNER MEDICAL PRODUCTS |
25 BELLINI AVE. |
BRAMPTON, ONTARIO,
CA
L6T 3Z8
|
|
Correspondent Contact |
NANCY LUM-WILSON |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 06/04/2001 |
Decision Date | 02/20/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|