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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K020017
Device Name MEDX 1000 SERIES
Applicant
Medx Electronics, Inc.
513 Bashford Ln.
Suite 5
Alexandria,  VA  22314
Applicant Contact ROBIN WILEY
Correspondent
Medx Electronics, Inc.
513 Bashford Ln.
Suite 5
Alexandria,  VA  22314
Correspondent Contact ROBIN WILEY
Regulation Number890.5500
Classification Product Code
ILY  
Date Received01/03/2002
Decision Date 07/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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