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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 K231596
Device Name IOB Temperature Management System
Applicant
Iob Medical, Inc.
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Applicant Contact Jonathan Kovach
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/01/2023
Decision Date 06/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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