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FDA 510(k) Application Details - K980609
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
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510(K) Number
K980609
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
METAGEN, L.L.C.
4329 GRAYDON RD.
SAN DIEGO, CA 92130 US
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Contact
FLOYD G LARSON
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Regulation Number
888.3020
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Classification Product Code
HSB
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More FDA Info for this Product Code
Date Received
02/17/1998
Decision Date
05/18/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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