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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sling, Arm
510(k) Number K823808
Device Name VARIOUS ARM SLING
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 Number890.3640
Classification Product Code
ILI  
Date Received12/17/1982
Decision Date 01/14/1983
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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