Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K970952 |
Device Name |
PRECISE IMPRESSION KIT |
Applicant |
STARKEY LABORATORIES, INC. |
6700 WASHINGTON AVE. SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
SHARI L SWIDEN |
Correspondent |
STARKEY LABORATORIES, INC. |
6700 WASHINGTON AVE. SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
SHARI L SWIDEN |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 03/14/1997 |
Decision Date | 05/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|