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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Skin Pressure
510(k) Number K771913
Device Name HEEL/ELBOW PROTECTOR
Applicant
Alba-Waldensian, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Alba-Waldensian, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6450
Classification Product Code
FMP  
Date Received10/11/1977
Decision Date 11/15/1977
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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