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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K992386
Device Name ALLON 2000
Applicant
Mtre Advanced Technology , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
Mtre Advanced Technology , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received07/16/1999
Decision Date 03/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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