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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Mattress (Medical Purposes)
510(k) Number K921928
Device Name SOFT-COVER
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 Number880.6190
Classification Product Code
FMW  
Date Received04/24/1992
Decision Date 11/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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