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
|
|
|