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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tong, Skull For Traction
510(k) Number K842680
Device Name ACE UNIVERSAL TONG
Applicant
BUCKMAN CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BUCKMAN CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5960
Classification Product Code
HAX  
Date Received07/10/1984
Decision Date 09/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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