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FDA 510(k) Application Details - K960023
Device Classification Name
Pin, Fixation, Threaded
More FDA Info for this Device
510(K) Number
K960023
Device Name
Pin, Fixation, Threaded
Applicant
PROMEX, INC.
1125 BROOKSIDE AVE.
SUITE G500
INDIANAPOLIS, IN 46202 US
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JOSEPH L MARK
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
JDW
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More FDA Info for this Product Code
Date Received
01/02/1996
Decision Date
03/18/1996
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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