Device Classification Name |
Cleaner, Air, Medical Recirculating
|
510(k) Number |
K930521 |
Device Name |
AIR CLEANERS WITH HEPA FILTRATION |
Applicant |
THE RIVAL CO. |
1001 GOLDEN DR. |
CLINTON,
MO
64735
|
|
Applicant Contact |
JAMES FERGUSON |
Correspondent |
THE RIVAL CO. |
1001 GOLDEN DR. |
CLINTON,
MO
64735
|
|
Correspondent Contact |
JAMES FERGUSON |
Regulation Number | 880.5045 |
Classification Product Code |
|
Date Received | 02/02/1993 |
Decision Date | 06/16/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|