Device Classification Name |
tube, tympanostomy
|
510(k) Number |
K822017 |
Device Name |
TYMPANOSTOMY TUBES & VARIOUS TYPES |
Applicant |
KELLEHER CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
KELLEHER CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 07/08/1982 |
Decision Date | 10/27/1982 |
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
|
|
|