Device Classification Name |
Calibrator, Hearing Aid / Earphone And Analysis Systems
|
510(k) Number |
K902244 |
Device Name |
RASTRONICS CCI 8 |
Applicant |
RASTRONICS USA, INC. |
5407 W. 79TH ST. |
P.O. BOX 78130 |
INDIANAPOLIS,
IN
46268 -8130
|
|
Applicant Contact |
ROBERT P WOLF |
Correspondent |
RASTRONICS USA, INC. |
5407 W. 79TH ST. |
P.O. BOX 78130 |
INDIANAPOLIS,
IN
46268 -8130
|
|
Correspondent Contact |
ROBERT P WOLF |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 05/18/1990 |
Decision Date | 10/05/1990 |
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
|
|
|