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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 K873693
Device Name LEVTECH COMPOSITE TRACTION TONGS
Applicant
LEVTECH, INC.
P.O. BOX 516
JACKSONVILLE,  FL  32201
Applicant Contact LEVON PENTECOST
Correspondent
LEVTECH, INC.
P.O. BOX 516
JACKSONVILLE,  FL  32201
Correspondent Contact LEVON PENTECOST
Regulation Number882.5960
Classification Product Code
HAX  
Date Received09/14/1987
Decision Date 02/05/1988
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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