| Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
| 510(k) Number |
K900632 |
| Device Name |
DYNASTY HEARING SYSTEMS INSTRUMENT |
| Applicant |
| Alastair Granville-Jackson, Mfa, Ed.D. |
| Chatham Sq. Medical Offices |
| 11 E. 17th St., 6th Floor |
|
New York,
NY
10003
|
|
| Applicant Contact |
GRANVILLE-JACKSON |
| Correspondent |
| Alastair Granville-Jackson, Mfa, Ed.D. |
| Chatham Sq. Medical Offices |
| 11 E. 17th St., 6th Floor |
|
New York,
NY
10003
|
|
| Correspondent Contact |
GRANVILLE-JACKSON |
| Regulation Number | 874.3300 |
| Classification Product Code |
|
| Date Received | 02/08/1990 |
| Decision Date | 09/12/1990 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|