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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 K960833
Device Name VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
Applicant
Uv Technologies, Inc.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ANNE MARIE CESARIO
Correspondent
Uv Technologies, Inc.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ANNE MARIE CESARIO
Regulation Number880.6500
Classification Product Code
FRA  
Date Received02/29/1996
Decision Date 07/25/1996
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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