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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K894170
Device Name DEVON DISPOSABLE HEAD POSITIONER COVER
Applicant
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Applicant Contact RUDY GABA
Correspondent
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Correspondent Contact RUDY GABA
Regulation Number880.6060
Classification Product Code
KME  
Date Received06/15/1989
Decision Date 09/07/1989
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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