Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K001149 |
FOIA Releasable 510(k) |
K001149
|
Device Name |
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK |
Applicant |
AUGUSTINE MEDICAL, INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
SCOTT D AUGUSTINE |
Correspondent |
AUGUSTINE MEDICAL, INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
SCOTT D AUGUSTINE |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 04/10/2000 |
Decision Date | 09/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|