Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K083493 |
Device Name |
MYOSCIENCE CRYO-TOUCH |
Applicant |
MYOSCIENCE INC |
525 CHESAPEAKE DRIVE |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
TRACEY HENRY |
Correspondent |
MYOSCIENCE INC |
525 CHESAPEAKE DRIVE |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
TRACEY HENRY |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 11/25/2008 |
Decision Date | 03/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|