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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K001228
Device Name EXTERNAL FIXATION ANCHOR PIN
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 Number888.3040
Classification Product Code
JDW  
Date Received04/17/2000
Decision Date 07/07/2000
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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