FDA 510(k) Application Details - K023959

Device Classification Name Tong, Skull For Traction

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510(K) Number K023959
Device Name Tong, Skull For Traction
Applicant THE JEROME GROUP, INC.
305 HARPER DR.
MOORESTOWN, NJ 08057 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 11/27/2002
Decision Date 02/21/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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