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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 K921920
Device Name SOFT-TEMP
Applicant
Adroit Medical Systems, Inc.
P.O. Box 0984
Morganton,  NC  28655
Applicant Contact SCOTT E GAMMONS
Correspondent
Adroit Medical Systems, Inc.
P.O. Box 0984
Morganton,  NC  28655
Correspondent Contact SCOTT E GAMMONS
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received04/23/1992
Decision Date 12/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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