FDA 510(k) Application Details - K020836

Device Classification Name Prosthesis, Hip, Cement Restrictor

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510(K) Number K020836
Device Name Prosthesis, Hip, Cement Restrictor
Applicant SIGNUS MEDICAL LLC.
4050 OLSON MEMORIAL HIGHWAY
SUITE 350
MINNEAPOLIS, MN 55422 US
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Contact ANN QUINLAN-SMITH
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Regulation Number 878.3300

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Classification Product Code JDK
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Date Received 03/14/2002
Decision Date 06/11/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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