Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K101092 |
Device Name |
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 |
Applicant |
MEDIVANCE, INC. |
321 SOUTH TAYLOR AVE, STE 200 |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
LYNNE ARONSON |
Correspondent |
MEDIVANCE, INC. |
321 SOUTH TAYLOR AVE, STE 200 |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
LYNNE ARONSON |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 04/20/2010 |
Decision Date | 07/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|