Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K030838 |
Device Name |
WARTNER PRO |
Applicant |
WARTNER MEDICAL PRODUCTS |
65 AVA CRESCENT |
RICHMOND HILL, ONTARIO,
CA
L4B 2X5
|
|
Applicant Contact |
NANCY LUM-WILSON |
Correspondent |
WARTNER MEDICAL PRODUCTS |
65 AVA CRESCENT |
RICHMOND HILL, ONTARIO,
CA
L4B 2X5
|
|
Correspondent Contact |
NANCY LUM-WILSON |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 03/17/2003 |
Decision Date | 06/27/2003 |
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
|
|
|