Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K163244 |
Device Name |
truFreeze System |
Applicant |
CSA MEDICAL, INC. |
91 HARTWELL AVENUE |
LEXINGTON,
MA
02421
|
|
Applicant Contact |
Sherrie Coval-Goldsmith |
Correspondent |
CSA MEDICAL, INC. |
91 HARTWELL AVENUE |
LEXINGTON,
MA
02421
|
|
Correspondent Contact |
Sherrie Coval-Goldsmith |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 11/18/2016 |
Decision Date | 05/24/2017 |
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
|
|
|