Device Classification Name |
Otoscope
|
510(k) Number |
K923304 |
Device Name |
FAMILY EAR SCOPE MODEL 29001S |
Applicant |
EAR CARE OF SO. CA., INC. |
3 WESTWICK CT. |
ANNAPOLIS,
MD
21403
|
|
Applicant Contact |
PLAVNER |
Correspondent |
EAR CARE OF SO. CA., INC. |
3 WESTWICK CT. |
ANNAPOLIS,
MD
21403
|
|
Correspondent Contact |
PLAVNER |
Regulation Number | 874.4770
|
Classification Product Code |
|
Date Received | 07/06/1992 |
Decision Date | 10/21/1992 |
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
|
|
|