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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 K083183
Device Name AKLARUS PHOTOTHERAPY SYSTEM
Applicant
Hill Laboratories Co.
3 N. Bacton Hill Rd.
Frazer,  PA  19355
Applicant Contact BRADY ALLER
Correspondent
Hill Laboratories Co.
3 N. Bacton Hill Rd.
Frazer,  PA  19355
Correspondent Contact BRADY ALLER
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Code
GEX  
Date Received10/28/2008
Decision Date 07/16/2009
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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