Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K913245 |
Device Name |
MODEL 80 HEARING AID DISPENSING SYSTEM |
Applicant |
3M COMPANY |
3M CENTER |
BLDG. 275-3SE-08 |
ST. PAUL,
MN
55144 -1000
|
|
Applicant Contact |
RALPH FRAVEL |
Correspondent |
3M COMPANY |
3M CENTER |
BLDG. 275-3SE-08 |
ST. PAUL,
MN
55144 -1000
|
|
Correspondent Contact |
RALPH FRAVEL |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/22/1991 |
Decision Date | 10/18/1991 |
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
|
|
|