Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K153541 |
Device Name |
Coldplay CryoBalloon® Ablation System |
Applicant |
C2 THERAPEUTICS, INC. |
303 CONVENTION WAY, SUITE 1 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
THERESA BRANDNER-ALLEN |
Correspondent |
C2 THERAPEUTICS, INC. |
303 CONVENTION WAY, SUITE 1 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
THERESA BRANDNER-ALLEN |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 12/10/2015 |
Decision Date | 01/07/2016 |
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
|
|
|