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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 K091497
Device Name K-LASER K-1200, MODEL 12 W
Applicant
Eltech S.R.L
311 S. Royal Oaks Blvd.
Suite 140-A
Franklin,  TN  37064
Applicant Contact RICHARD ALBRIGHT
Correspondent
Eltech S.R.L
311 S. Royal Oaks Blvd.
Suite 140-A
Franklin,  TN  37064
Correspondent Contact RICHARD ALBRIGHT
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/20/2009
Decision Date 08/19/2009
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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