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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 K021985
Device Name MEDX LCS LASER SERIES
Applicant
Medx Electronics, Inc.
3535 Laird Rd., Unit 2
Mississauga, Ontario,  CA L5L 5Y7
Applicant Contact ANITA SALTMARCHE
Correspondent
Medx Electronics, Inc.
3535 Laird Rd., Unit 2
Mississauga, Ontario,  CA L5L 5Y7
Correspondent Contact ANITA SALTMARCHE
Regulation Number890.5500
Classification Product Code
NHN  
Date Received06/18/2002
Decision Date 09/10/2002
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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