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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 K934914
Device Name ICS 9400 ULTRAVIOLET AIR PURIFIER
Applicant
Medair, Inc.
8920 Business Park Dr.
Suite 120-A
Austin,  TX  78759
Applicant Contact WILLIAM S EBERSOLE
Correspondent
Medair, Inc.
8920 Business Park Dr.
Suite 120-A
Austin,  TX  78759
Correspondent Contact WILLIAM S EBERSOLE
Regulation Number880.6500
Classification Product Code
FRA  
Date Received10/13/1993
Decision Date 04/13/1994
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
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