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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 Rd., Suite 7
Rocklin,  CA  95765
Applicant Contact FRANK L WEGENER
Correspondent
L&H Airco
3835 Atherton Rd., Suite 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
Predetermined Change
Control Plan Authorized		 No
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