Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K073533 |
Device Name |
SANARUS V2 TREATMENT SYSTEM |
Applicant |
SANARUS MEDICAL, INC. |
4696 WILLOW RD. |
PLEASANTON,
CA
94588
|
|
Applicant Contact |
LISA HENRY |
Correspondent |
SANARUS MEDICAL, INC. |
4696 WILLOW RD. |
PLEASANTON,
CA
94588
|
|
Correspondent Contact |
LISA HENRY |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 12/17/2007 |
Decision Date | 02/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|