| Device Classification Name |
Purifier, Air, Ultraviolet, Medical
|
| 510(k) Number |
K023830 |
| FOIA Releasable 510(k) |
K023830
|
| Device Name |
AIROCIDE TI02 |
| Applicant |
| Kes Science & Technology, Inc. |
| 3625 Kennesaw N.Industrial Pky |
|
Kennesaw,
GA
30144
|
|
| Applicant Contact |
JOHN HAYMAN, JR |
| Correspondent |
| Kes Science & Technology, Inc. |
| 3625 Kennesaw N.Industrial Pky |
|
Kennesaw,
GA
30144
|
|
| Correspondent Contact |
JOHN HAYMAN, JR |
| Regulation Number | 880.6500 |
| Classification Product Code |
|
| Date Received | 11/18/2002 |
| Decision Date | 02/04/2003 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|