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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Traction
510(k) Number K921711
Device Name FLEXION DISTRATION SUPPORT
Applicant
Altoona Medical Supply
705 2nd Ave., SW
Altoona,  IA  50009
Applicant Contact DONALD A MACKENZIE
Correspondent
Altoona Medical Supply
705 2nd Ave., SW
Altoona,  IA  50009
Correspondent Contact DONALD A MACKENZIE
Regulation Number890.5925
Classification Product Code
ILZ  
Date Received04/08/1992
Decision Date 07/13/1992
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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