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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 K102112
Device Name CRITICOOL PRO
Applicant
MTRE ADVANCED TECHNOLOGY LTD.
4 ha-yarden st.
(p.o.box 102 rehovot 76100)
yavne,  IL 81228
Applicant Contact ifat oren
Correspondent
MTRE ADVANCED TECHNOLOGY LTD.
4 ha-yarden st.
(p.o.box 102 rehovot 76100)
yavne,  IL 81228
Correspondent Contact ifat oren
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received07/28/2010
Decision Date 11/18/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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