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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 K073352
Device Name WEBERNEEDLE BASIC LASER
Applicant
Weber Medical GmbH
Sohnreystrasse 6
Lauenförde,  DE 37697
Applicant Contact JURGEN HERMANN
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFFREY RONGERO
Regulation Number890.5500
Classification Product Code
ILY  
Date Received11/29/2007
Decision Date 08/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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