Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K974751 |
Device Name |
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC |
Applicant |
GENERAL HEARING INSTRUMENTS, INC. |
175 BROOKHOLLOW ESPL. |
HARAHAN,
LA
70123
|
|
Applicant Contact |
ROGER P JUNEAU |
Correspondent |
GENERAL HEARING INSTRUMENTS, INC. |
175 BROOKHOLLOW ESPL. |
HARAHAN,
LA
70123
|
|
Correspondent Contact |
ROGER P JUNEAU |
Regulation Number | 874.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/19/1997 |
Decision Date | 03/06/1998 |
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
|
|
|