FDA 510(k) Application Details - K122263

Device Classification Name Tunneled Catheter Remover

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510(K) Number K122263
Device Name Tunneled Catheter Remover
Applicant SYMMETRY MEDICAL
3034 OWEN DRIVE
ANTIOCH, TN 37013 US
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Contact HANNAH FOLEY
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Regulation Number 880.5970

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Classification Product Code ODY
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Date Received 07/27/2012
Decision Date 09/28/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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