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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number880.6500
Classification Product Code
FRA  
Date Received11/18/2002
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
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