Device Classification Name |
Disinfector, Medical Devices
|
510(k) Number |
K081094 |
Device Name |
OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 |
Applicant |
OLYMPIC MEDICAL CORP. |
5900 FIRST AVE., SOUTH |
SEATTLE,
WA
98108
|
|
Applicant Contact |
STEVE HESLER |
Correspondent |
OLYMPIC MEDICAL CORP. |
5900 FIRST AVE., SOUTH |
SEATTLE,
WA
98108
|
|
Correspondent Contact |
STEVE HESLER |
Regulation Number | 880.6992
|
Classification Product Code |
|
Date Received | 04/17/2008 |
Decision Date | 06/20/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|