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FDA 510(k) Application Details - K991962
Device Classification Name
Staple, Fixation, Bone
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510(K) Number
K991962
Device Name
Staple, Fixation, Bone
Applicant
GROUPE LEPINE
962 SOUTH TAMIAMI TRAIL
SUITE 203
SARASOTA, FL 34326 US
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Contact
DOUGLAS W STUART
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Regulation Number
888.3030
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Classification Product Code
JDR
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More FDA Info for this Product Code
Date Received
06/10/1999
Decision Date
01/10/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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