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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 K932687
Device Name AME(R) UNIVERSIAL CABLE SYSTEM
Applicant
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Applicant Contact KEITH JUNG
Correspondent
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Correspondent Contact KEITH JUNG
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received06/03/1993
Decision Date 05/03/1994
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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