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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K034009
Device Name LAPEX 2000
Applicant
Meridian Co., Ltd.
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Meridian Co., Ltd.
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number890.5500
Classification Product Code
NHN  
Date Received12/24/2003
Decision Date 01/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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