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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K150789
Device Name SPINAUT-E, SPINAUT-I
Applicant
IMEDICOM CO., LTD.
#612, 172, LS-ro
Gunpo-si,  KR 435-824
Applicant Contact Bonngu Ha
Correspondent
LK Consulting Group USA, Inc.
2651 E Chapman Ave Ste 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number868.5120
Classification Product Code
BSO  
Date Received03/25/2015
Decision Date 03/01/2016
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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