Device Classification Name |
Applicator, Ent
|
510(k) Number |
K894369 |
Device Name |
APDYNE PHENOL APPLICATOR KIT |
Applicant |
APDYNE MEDICAL CO. |
955 WEST IDAHO AVE. |
SAINT PAUL,
MN
55117
|
|
Applicant Contact |
MICHAEL W WALSH |
Correspondent |
APDYNE MEDICAL CO. |
955 WEST IDAHO AVE. |
SAINT PAUL,
MN
55117
|
|
Correspondent Contact |
MICHAEL W WALSH |
Regulation Number | 874.5220
|
Classification Product Code |
|
Date Received | 07/14/1989 |
Decision Date | 10/12/1989 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|