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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 K933454
Device Name DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM
Applicant
L&H AIRCO
3835 atherton road, ste. 7
rocklin,  CA  95765
Applicant Contact frank l wegener
Correspondent
L&H AIRCO
3835 atherton road, ste. 7
rocklin,  CA  95765
Correspondent Contact frank l wegener
Regulation Number880.6500
Classification Product Code
FRA  
Date Received07/14/1993
Decision Date 09/16/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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