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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Exercise
510(k) Number K813632
Device Name COLOR CODED WEIGHT CUFFS
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 Number890.5350
Classification Product Code
IOD  
Date Received12/29/1981
Decision Date 01/19/1982
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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