FDA 510(k) Application Details - K071173

Device Classification Name Tong, Skull For Traction

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510(K) Number K071173
Device Name Tong, Skull For Traction
Applicant OSSUR AMERICANS (FORMERLY THE JEROME GROUP)
1414 METROPOLITAN AVENUE
PAULSBORO, NJ 08066 US
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Contact BERNIE TATRO
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Regulation Number 882.5960

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Classification Product Code HAX
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Date Received 04/27/2007
Decision Date 05/25/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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