Device Classification Name |
otoscope
|
510(k) Number |
K911650 |
Device Name |
PEDIA PALS |
Applicant |
PEDIA PALS, INC. |
P.O. BOX 21934 |
1964 COLLINGWOOD ROAD |
COLUMBUS,
OH
43221
|
|
Applicant Contact |
HANSEL, JR. |
Correspondent |
PEDIA PALS, INC. |
P.O. BOX 21934 |
1964 COLLINGWOOD ROAD |
COLUMBUS,
OH
43221
|
|
Correspondent Contact |
HANSEL, JR. |
Regulation Number | 874.4770
|
Classification Product Code |
|
Date Received | 04/12/1991 |
Decision Date | 10/17/1991 |
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
|
|
|