FDA 510(k) Application Details - K240253

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

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510(K) Number K240253
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant Aerin Medical Inc.
2565 Leghorn St.
Mountain View, CA 94043 US
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Contact Teri Feeley
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 01/30/2024
Decision Date 03/21/2024
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

FDA Source Information for K240253


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