Device Classification Name |
lamp, infrared, therapeutic heating
|
510(k) Number |
K001056 |
Device Name |
OLYMPIC WARM-UP |
Applicant |
OLYMPIC MEDICAL CORP. |
5900 FIRST AVE., SOUTH |
SEATTLE,
WA
98108
|
|
Applicant Contact |
JOSEPH P STEFANILE |
Correspondent |
OLYMPIC MEDICAL CORP. |
5900 FIRST AVE., SOUTH |
SEATTLE,
WA
98108
|
|
Correspondent Contact |
JOSEPH P STEFANILE |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 04/03/2000 |
Decision Date | 09/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|