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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 K001003
Device Name Z-NET
Applicant
Demite Limited
1001 Pennsylvania Ave. Nw.
6th Floor
Washington,  DC  20004
Applicant Contact WILLIAM H.E. VON OEHSEN
Correspondent
Demite Limited
1001 Pennsylvania Ave. Nw.
6th Floor
Washington,  DC  20004
Correspondent Contact WILLIAM H.E. VON OEHSEN
Regulation Number880.6190
Classification Product Code
FMW  
Date Received03/29/2000
Decision Date 12/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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