Device Classification Name |
stimulator, nerve
|
510(k) Number |
K912508 |
Device Name |
NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION |
Applicant |
RLN SYSTEMS, INC. |
2019 HONEYSUCKLE LN. |
P.O. BOX 6757 |
JEFFERSON CITY,
MO
65109
|
|
Applicant Contact |
LEE REA |
Correspondent |
RLN SYSTEMS, INC. |
2019 HONEYSUCKLE LN. |
P.O. BOX 6757 |
JEFFERSON CITY,
MO
65109
|
|
Correspondent Contact |
LEE REA |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 06/06/1991 |
Decision Date | 09/30/1992 |
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
|
|
|