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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 K924477
Device Name WIPEABLE PILLOW
Applicant
Perfect Fit Industries, Inc.
3300 Ncnb Plaza
Charlotte,  NC  28280
Applicant Contact BRIAN C REEVE
Correspondent
Perfect Fit Industries, Inc.
3300 Ncnb Plaza
Charlotte,  NC  28280
Correspondent Contact BRIAN C REEVE
Regulation Number880.6190
Classification Product Code
FMW  
Date Received09/03/1992
Decision Date 01/29/1993
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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