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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
510(k) Number K970290
Device Name EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
Applicant
Ebi, L.P.
6 Upper Pond Rd.
Parsippany,  NJ  07054
Applicant Contact JON CAPAROTTA
Correspondent
Ebi, L.P.
6 Upper Pond Rd.
Parsippany,  NJ  07054
Correspondent Contact JON CAPAROTTA
Regulation Number888.3030
Classification Product Code
KTT  
Date Received01/24/1997
Decision Date 04/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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