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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K910128
Device Name LEVTECH TITANIUM BONE WIRE
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 Number888.3010
Classification Product Code
JDQ  
Date Received01/09/1991
Decision Date 06/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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