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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 K090250
Device Name ELECTRO-LIGHT THERAPY
Applicant
Hill Laboratories Co.
3 Bacton Hill Rd.
Frazer,  PA  19355
Applicant Contact BRADY ALLER
Correspondent
Hill Laboratories Co.
3 Bacton Hill Rd.
Frazer,  PA  19355
Correspondent Contact BRADY ALLER
Regulation Number890.5500
Classification Product Code
ILY  
Date Received02/02/2009
Decision Date 02/11/2010
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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