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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 K120604
Device Name K-LASER
Applicant
Eltech S.R.L
1185 W. Main St.
Franklin,  TN  37064
Applicant Contact RICHARD ALBRIGHT
Correspondent
Eltech S.R.L
1185 W. Main St.
Franklin,  TN  37064
Correspondent Contact RICHARD ALBRIGHT
Regulation Number890.5500
Classification Product Code
ILY  
Date Received02/28/2012
Decision Date 05/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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