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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 K050022
Device Name MEDX HOME
Applicant
MEDX ELECTRONICS, INC.
3350 RIDGEWAY DRIVE UNIT 3
mississauga on,  CA l5l 5z9
Applicant Contact anita saltmarche
Correspondent
MEDX ELECTRONICS, INC.
3350 RIDGEWAY DRIVE UNIT 3
mississauga on,  CA l5l 5z9
Correspondent Contact anita saltmarche
Regulation Number890.5500
Classification Product Code
ILY  
Date Received01/05/2005
Decision Date 05/05/2005
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
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