Device Classification Name |
unit, examining/treatment, ent
|
510(k) Number |
K822252 |
Device Name |
ENT TREATMENT UNITS |
Applicant |
KELLEHER CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
KELLEHER CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 874.5300
|
Classification Product Code |
|
Date Received | 07/29/1982 |
Decision Date | 11/22/1982 |
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
|
|
|