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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K240253
Device Name Reach Needle
Applicant
Aerin Medical Inc.
2565 Leghorn St.
Mountain View,  CA  94043
Applicant Contact Teri Feeley
Correspondent
Aerin Medical Inc.
2565 Leghorn St.
Mountain View,  CA  94043
Correspondent Contact Teri Feeley
Regulation Number868.5150
Classification Product Code
BSP  
Date Received01/30/2024
Decision Date 03/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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