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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Lumbo-Sacral
510(k) Number K823823
Device Name LUMBOSACRAL SUPPORT
Applicant
Danek Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Danek Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.3490
Classification Product Code
IPY  
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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