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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 K221669
Device Name IOB Warming Blankets
Applicant
Iob Medical, Inc.
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Applicant Contact Jiulin Xia
Correspondent
LSI International, Inc.
504 E Diamond Ave., Suite J
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/09/2022
Decision Date 12/27/2022
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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