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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K871539
Device Name ZINDRICK IM ROD
Applicant
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/20/1987
Decision Date 08/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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