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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 K792586
Device Name HALO SUPPORT JACKET & ASSOC. HARDWARE
Applicant
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5960
Classification Product Code
HAX  
Date Received12/17/1979
Decision Date 12/31/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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