Device Classification Name |
stimulator, nerve
|
510(k) Number |
K003745 |
Device Name |
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET |
Applicant |
RLN SYSTEMS, INC. |
2019 HONEYSUCKLE LN. |
P.O. BOX 6757 |
JEFFERSON CITY,
MO
65109
|
|
Applicant Contact |
J. LEE REA |
Correspondent |
RLN SYSTEMS, INC. |
2019 HONEYSUCKLE LN. |
P.O. BOX 6757 |
JEFFERSON CITY,
MO
65109
|
|
Correspondent Contact |
J. LEE REA |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 12/04/2000 |
Decision Date | 01/16/2001 |
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
|
Recalls |
CDRH Recalls
|
|
|