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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 K062716
Device Name ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
Applicant
Eco-Rx, Inc.
34 Ave. St. Denis
Quebec City, Qc,  CA G1R-4B6
Applicant Contact CONSTANCE R BROWN, ESQ.
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number880.6500
Classification Product Code
FRA  
Date Received09/12/2006
Decision Date 10/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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