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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Limb
510(k) Number K761114
Device Name FOAM SLIPPERS
Applicant
Fred Sammons, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fred Sammons, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3025
Classification Product Code
IPM  
Date Received11/19/1976
Decision Date 12/02/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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