Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K041783 |
Device Name |
POLAR WAND |
Applicant |
CHEK-MED SYSTEMS |
25 VILLAGE HILL RD. |
WILLINGTON,
CT
06279
|
|
Applicant Contact |
ROB WHALEN |
Correspondent |
CHEK-MED SYSTEMS |
25 VILLAGE HILL RD. |
WILLINGTON,
CT
06279
|
|
Correspondent Contact |
ROB WHALEN |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 07/01/2004 |
Decision Date | 09/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|