Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K072651 |
Device Name |
CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM |
Applicant |
CSA MEDICAL, INC. |
1101 E. 33RD STREET |
THIRD FLOOR - #E305 |
BALTIMORE,
MD
21218
|
|
Applicant Contact |
JENNIFER CARTLEDGE |
Correspondent |
CSA MEDICAL, INC. |
1101 E. 33RD STREET |
THIRD FLOOR - #E305 |
BALTIMORE,
MD
21218
|
|
Correspondent Contact |
JENNIFER CARTLEDGE |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 09/19/2007 |
Decision Date | 12/07/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|