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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 K832233
Device Name EPINEED EPIDURAL NEEDLE
Applicant
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Regulation Number868.5150
Classification Product Code
BSP  
Date Received07/11/1983
Decision Date 08/08/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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