Device Classification Name |
Electrode, Needle, Diagnostic Electromyograph
|
510(k) Number |
K960591 |
Device Name |
RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP |
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 | 02/12/1996 |
Decision Date | 06/13/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|