Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K131523 |
Device Name |
CRYOBALLOON FOCAL ABLATION SYSTEM |
Applicant |
C2 THERAPEUTICS |
303 CONVENTION WAY |
SUITE 1 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
PETER GARCIA-MEZA |
Correspondent |
C2 THERAPEUTICS |
303 CONVENTION WAY |
SUITE 1 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
PETER GARCIA-MEZA |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 05/28/2013 |
Decision Date | 08/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|