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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 K980609
Device Name SEGMENTAL DEFECT REPLACEMENT SYSTEM
Applicant
METAGEN, L.L.C.
4329 GRAYDON RD.
SAN DIEGO,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
METAGEN, L.L.C.
4329 GRAYDON RD.
SAN DIEGO,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/17/1998
Decision Date 05/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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