Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K022903 |
Device Name |
CHILLBUSTER |
Applicant |
MICROTEK MEDICAL, INC. |
512 LEHMBERG RD. |
COLUMBUS,
MS
39702
|
|
Applicant Contact |
THOMAS BONNER |
Correspondent |
MICROTEK MEDICAL, INC. |
512 LEHMBERG RD. |
COLUMBUS,
MS
39702
|
|
Correspondent Contact |
THOMAS BONNER |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 09/03/2002 |
Decision Date | 11/27/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|