Device Classification Name |
tube, shunt, endolymphatic with valve
|
510(k) Number |
K972383 |
Device Name |
EASY-JET DEVICE |
Applicant |
A. STEIN - REGULATORY AFFAIRS CONSULTING |
P.O.B. 454 |
GINOT SHOMRON,
IL
44853
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
A. STEIN - REGULATORY AFFAIRS CONSULTING |
P.O.B. 454 |
GINOT SHOMRON,
IL
44853
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 874.3850
|
Classification Product Code |
|
Date Received | 06/26/1997 |
Decision Date | 11/23/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|