FDA 510(k) Application Details - K022821

Device Classification Name Wire, Fixation, Intraosseous

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510(K) Number K022821
Device Name Wire, Fixation, Intraosseous
Applicant IDEATRICS, INC.
7341 SOUTH MEADOW CT.
BOULDER, CO 80301 US
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Contact JAMES W HELLER
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Regulation Number 872.4880

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Classification Product Code DZK
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Date Received 08/26/2002
Decision Date 11/15/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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