FDA 510(k) Application Details - K991259

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K991259
Device Name Catheter, Conduction, Anesthetic
Applicant TE ME NA S.A.R.L.
390 SCARLET BLVD.
OLDSMAR, FL 34677 US
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Contact JOE HARMS
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Regulation Number 868.5120

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Classification Product Code BSO
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Date Received 04/13/1999
Decision Date 02/21/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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