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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K001084
Device Name TRANS FX ADJUSTABLE PIN TO BAR CLAMP
Applicant
IMMEDICA, INC.
100 PASSAIC AVE.
CHATHAM,  NJ  07928 -2848
Applicant Contact ROY BOGERT
Correspondent
IMMEDICA, INC.
100 PASSAIC AVE.
CHATHAM,  NJ  07928 -2848
Correspondent Contact ROY BOGERT
Regulation Number888.3030
Classification Product Code
LXT  
Date Received04/04/2000
Decision Date 06/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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