Device Classification Name |
Electrode, Needle, Diagnostic Electromyograph
|
510(k) Number |
K152984 |
Device Name |
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes |
Applicant |
BIO PROTECH, INC. |
DONGHWA MEDICAL INSTRUMENT COMPLEX, 151-3, |
DONGHWAGONDAN-RO, MUNMAK-EUP |
WONJU-SI,
KR
220-801
|
|
Applicant Contact |
DANIEL WOO |
Correspondent |
BIO PROTECH USA, INC. |
2601 WALNUT AVE |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
KEVIN HAN |
Regulation Number | 890.1385
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/09/2015 |
Decision Date | 06/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|