FDA 510(k) Application Details - K110858

Device Classification Name Apparatus, Traction, Non-Powered

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510(K) Number K110858
Device Name Apparatus, Traction, Non-Powered
Applicant ROLAND F BERTHIAUME, DC
585 COOLEY STREET
SPRINGFIELD, MA 01128 US
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Contact ROLAND F BERTHIAUME
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Regulation Number 888.5850

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Classification Product Code HST
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Date Received 03/28/2011
Decision Date 08/02/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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