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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 K101227
Device Name BACK-TEK
Applicant
York Biomedical, Inc.
13417 Quivas St.
Westminster,  CO  80234
Applicant Contact Calley Herzog
Correspondent
York Biomedical, Inc.
13417 Quivas St.
Westminster,  CO  80234
Correspondent Contact Calley Herzog
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/03/2010
Decision Date 06/23/2010
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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