Device Classification Name |
Catheter, Conduction, Anesthetic
|
510(k) Number |
K173541 |
Device Name |
EPINAUT |
Applicant |
Imedicom Co., Ltd. |
#612, 172, LS-ro |
Gunpo-si,
KR
435824
|
|
Applicant Contact |
Priscilla Chung |
Correspondent |
LK Consulting Group USA, Inc. |
690 Roosevelt, |
Irvine,
CA
92620
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 11/15/2017 |
Decision Date | 08/24/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|