FDA 510(k) Application Details - K993099

Device Classification Name Component, Traction, Invasive

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510(K) Number K993099
Device Name Component, Traction, Invasive
Applicant DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact FRANK MASS
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Regulation Number 888.3040

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Classification Product Code JEC
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Date Received 09/16/1999
Decision Date 12/15/1999
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

FDA Source Information for K993099


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