Device Classification Name |
Stimulator, Nerve
|
510(k) Number |
K954601 |
Device Name |
NERVE LOCATOR/MONITOR SYSTEM MODIFICATION |
Applicant |
RLN SYSTEMS, INC. |
1021 NORTHEAST DR. |
JEFFERSON CITY,
MO
65109
|
|
Applicant Contact |
J. LEE REA |
Correspondent |
RLN SYSTEMS, INC. |
1021 NORTHEAST DR. |
JEFFERSON CITY,
MO
65109
|
|
Correspondent Contact |
J. LEE REA |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 09/12/1995 |
Decision Date | 12/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|