Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K881349 |
Device Name |
VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM |
Applicant |
CRYOSURG, INC. |
7356 CABOT DR. |
NASHVILLE,
TN
37209
|
|
Applicant Contact |
MCDOW, MD |
Correspondent |
CRYOSURG, INC. |
7356 CABOT DR. |
NASHVILLE,
TN
37209
|
|
Correspondent Contact |
MCDOW, MD |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 03/30/1988 |
Decision Date | 06/30/1988 |
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
|
|
|