Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K161294 |
Device Name |
Compound W Wart Removal System Dual Power |
Applicant |
MEDTECH PRODUCTS INC. |
660 WHITE PLAINS ROAD |
Tarrytown,
NY
10591
|
|
Applicant Contact |
JEAN BOYKO |
Correspondent |
EMERGO GLOBAL CONSULTING, LLC |
816 CONGRESS AVE |
SUITE 1400 |
Austin,
TX
78701
|
|
Correspondent Contact |
KATHRYN A. CORESSEL |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 05/09/2016 |
Decision Date | 09/15/2016 |
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 |
Yes
|