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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 K122125
Device Name ASA LASER SH1
Applicant
EL.EN. ELECTRONIC ENGINEERING SPA
17 VIA BALDANZESE
CALENZANO,  IT 50041
Applicant Contact PAOLO PERUZZI
Correspondent
EL.EN. ELECTRONIC ENGINEERING SPA
17 VIA BALDANZESE
CALENZANO,  IT 50041
Correspondent Contact PAOLO PERUZZI
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/18/2012
Decision Date 01/25/2013
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
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