Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K910761 |
Device Name |
3M MODEL 8243 ITE HEARING AID |
Applicant |
3M COMPANY |
3M CENTER |
BLDG. 275-3SE-08 |
ST. PAUL,
MN
55144 -1000
|
|
Applicant Contact |
JOYCE K EYERLY |
Correspondent |
3M COMPANY |
3M CENTER |
BLDG. 275-3SE-08 |
ST. PAUL,
MN
55144 -1000
|
|
Correspondent Contact |
JOYCE K EYERLY |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 02/19/1991 |
Decision Date | 02/28/1991 |
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
|
|
|