FDA 510(k) Application Details - K111031

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K111031
Device Name Catheter, Conduction, Anesthetic
Applicant PLAN 1 HEALTH, S.R.L.
2400 VIA CARILLO
PALOS VERDES ESTATES, CA 90274 US
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Contact SIGI CARON
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Regulation Number 868.5120

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Classification Product Code BSO
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Date Received 04/14/2011
Decision Date 07/08/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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