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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 K031612
Device Name ALT LASER, MODEL VTR 75
Applicant
Avicenna Laser Technology, Inc.
1209 N. Flagler Dr.
West Palm Beach,  FL  33401
Applicant Contact BRUCE R COREN
Correspondent
Avicenna Laser Technology, Inc.
1209 N. Flagler Dr.
West Palm Beach,  FL  33401
Correspondent Contact BRUCE R COREN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/22/2003
Decision Date 12/11/2003
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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