Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K152337 |
Device Name |
cryoFORM cryoICE cryoablation probe |
Applicant |
ATRICURE, INC |
6217 CENTRE PARK DR |
WEST CHESTER,
OH
45069
|
|
Applicant Contact |
JONATHAN MCELWEE |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 08/19/2015 |
Decision Date | 03/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|