| 510(k) Number |
K850186 |
| Device Name |
POST AURICULAR HEARING AIDS STAR 33PP, 44,55F & |
| Applicant |
| Robert Bosch Corp. |
| Flower Field Bldg. #17 |
| Mill Pond Rd. |
|
St. James,
NY
11780
|
|
| Applicant Contact |
CHERYL M LEISTER |
| Correspondent |
| Robert Bosch Corp. |
| Flower Field Bldg. #17 |
| Mill Pond Rd. |
|
St. James,
NY
11780
|
|
| Correspondent Contact |
CHERYL M LEISTER |
| Date Received | 01/18/1985 |
| Decision Date | 03/27/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|