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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K960023
Device Name KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
Applicant
PROMEX, INC.
1125 BROOKSIDE AVE.
SUITE G500
INDIANAPOLIS,  IN  46202
Applicant Contact JOSEPH L MARK
Correspondent
PROMEX, INC.
1125 BROOKSIDE AVE.
SUITE G500
INDIANAPOLIS,  IN  46202
Correspondent Contact JOSEPH L MARK
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
HTY  
Date Received01/02/1996
Decision Date 03/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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