FDA 510(k) Application Details - K090733

Device Classification Name Tong, Skull For Traction

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510(K) Number K090733
Device Name Tong, Skull For Traction
Applicant PMT CORP.
1500 PARK RD.
P.O. OX 610
CHANHASSEN, MN 55317 US
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Contact ERIC CAILLE
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Regulation Number 882.5960

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Classification Product Code HAX
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Date Received 03/19/2009
Decision Date 07/28/2009
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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