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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 K171087
Device Name AXON IR Heat Lamp
Applicant
Crystal Medtech, LLC
4704 Bayberry St.
Schofield,  WI  54476
Applicant Contact Nelson Marquina
Correspondent
Crystal Medtech, LLC
4704 Bayberry St.
Schofield,  WI  54476
Correspondent Contact Nelson Marquina
Regulation Number890.5500
Classification Product Code
ILY  
Date Received04/12/2017
Decision Date 07/07/2017
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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