Device Classification Name |
system, thermal regulating
|
510(k) Number |
K071341 |
Device Name |
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 |
Applicant |
MEDIVANCE, INC. |
1172 CENTURY DR., SUITE 240 |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
LYNNE ARONSON |
Correspondent |
MEDIVANCE, INC. |
1172 CENTURY DR., SUITE 240 |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
LYNNE ARONSON |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 05/14/2007 |
Decision Date | 08/03/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|