Device Classification Name |
Electrode, Needle, Diagnostic Electromyograph
|
510(k) Number |
K955335 |
Device Name |
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE |
Applicant |
CHALGREN ENTERPRISES, INC. |
8021 CARMEL ST. |
SUITE B |
GILROY,
CA
95020
|
|
Applicant Contact |
RICHARD KAISER |
Correspondent |
CHALGREN ENTERPRISES, INC. |
8021 CARMEL ST. |
SUITE B |
GILROY,
CA
95020
|
|
Correspondent Contact |
RICHARD KAISER |
Regulation Number | 890.1385
|
Classification Product Code |
|
Date Received | 11/20/1995 |
Decision Date | 01/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|