Device Classification Name |
Tube, Tympanostomy
|
510(k) Number |
K973740 |
Device Name |
ROUND WINDOW E-CATH |
Applicant |
NEURO-BIOMETRIX, INC. |
7995 EAST PRENTICE AVE. |
ENGLEWOOD,
CO
80111 -2710
|
|
Applicant Contact |
MICHAEL H ARENBERG |
Correspondent |
NEURO-BIOMETRIX, INC. |
7995 EAST PRENTICE AVE. |
ENGLEWOOD,
CO
80111 -2710
|
|
Correspondent Contact |
MICHAEL H ARENBERG |
Regulation Number | 874.3880
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/01/1997 |
Decision Date | 03/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|