| Device Classification Name |
Purifier, Air, Ultraviolet, Medical
|
| 510(k) Number |
K884579 |
| Device Name |
UV AIR STERILIGHT |
| Applicant |
| Allseasons Environmental Control, Inc. |
| 331 Exeter Rd., Units 23-25 |
|
London, Ontario,
CA
|
|
| Applicant Contact |
DAVID RITCHIE |
| Correspondent |
| Allseasons Environmental Control, Inc. |
| 331 Exeter Rd., Units 23-25 |
|
London, Ontario,
CA
|
|
| Correspondent Contact |
DAVID RITCHIE |
| Regulation Number | 880.6500 |
| Classification Product Code |
|
| Date Received | 11/03/1988 |
| Decision Date | 12/12/1988 |
| 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
|
|
|