FDA 510(k) Application Details - K141126

Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)

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510(K) Number K141126
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant UNISIS CORP.
1201 RICHARDSON DRIVE, SUITE 280
RICHARDSON, TX 75080 US
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Contact DIANE RUTHERFORD
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 05/01/2014
Decision Date 10/31/2014
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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