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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 K935220
Device Name CORE PREVENT MATTRESS MODIFICATION
Applicant
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082 -0560
Applicant Contact ELAINE DUNCAN
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082 -0560
Correspondent Contact ELAINE DUNCAN
Regulation Number880.6190
Classification Product Code
FMW  
Subsequent Product Code
IKY  
Date Received10/12/1993
Decision Date 11/29/1993
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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