| Device Classification Name |
Protector, Hearing (Insert)
|
| 510(k) Number |
K945376 |
| Device Name |
DOC'S PROPLUGS EAR PLUGS |
| Applicant |
| Doc'S Proplugs, Inc. |
| 416 Lighthouse Ave. |
|
Santa Cruz,
CA
95060
|
|
| Applicant Contact |
ROBERT T SCOTT |
| Correspondent |
| Doc'S Proplugs, Inc. |
| 416 Lighthouse Ave. |
|
Santa Cruz,
CA
95060
|
|
| Correspondent Contact |
ROBERT T SCOTT |
| Classification Product Code |
|
| Date Received | 10/21/1994 |
| Decision Date | 11/14/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ear Nose & Throat
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|