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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 K942300
Device Name SILKON TITANIUM CABLE SYSTEM
Applicant
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Applicant Contact MARY BRIGGERS
Correspondent
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Correspondent Contact MARY BRIGGERS
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received05/12/1994
Decision Date 01/09/1995
Decision Substantially Equivalent - Kit (SESK)
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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