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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Lumbar
510(k) Number K810450
Device Name TRUNCAL ORTHOSIS
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 Number890.3490
Classification Product Code
IQE  
Date Received02/19/1981
Decision Date 03/04/1981
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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