Device Classification Name |
Otoscope
|
510(k) Number |
K915537 |
Device Name |
EARBEAR OTOSCOPE |
Applicant |
EARBEAR CO. |
4279 BRIGADOON DR. |
SHOREVIEW,
MN
56126
|
|
Applicant Contact |
PAUL A BURGIO |
Correspondent |
EARBEAR CO. |
4279 BRIGADOON DR. |
SHOREVIEW,
MN
56126
|
|
Correspondent Contact |
PAUL A BURGIO |
Regulation Number | 874.4770
|
Classification Product Code |
|
Date Received | 12/10/1991 |
Decision Date | 01/24/1992 |
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
|
|
|