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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 K133800
Device Name ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI
Applicant
Hgi Industires
2055 High Ridge Rd.
Boynton Beach,  FL  33426
Applicant Contact CONNIE ARAPS, PHD
Correspondent
Hgi Industires
2055 High Ridge Rd.
Boynton Beach,  FL  33426
Correspondent Contact CONNIE ARAPS, PHD
Regulation Number880.6500
Classification Product Code
FRA  
Date Received12/13/2013
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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