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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Rib Fracture, Soft
510(k) Number K803239
Device Name SOFTGOOD PRODUCTS AND SPLINTS
Applicant
Danek Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Danek Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3490
Classification Product Code
IPX  
Date Received12/23/1980
Decision Date 01/09/1981
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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