Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K964245 |
Device Name |
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS |
Applicant |
STARKEY LABORATORIES, INC. |
6600-6700 WASHINGTON AVE.SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
SHARI L SWIDEN |
Correspondent |
STARKEY LABORATORIES, INC. |
6600-6700 WASHINGTON AVE.SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
SHARI L SWIDEN |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 10/24/1996 |
Decision Date | 02/04/1997 |
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
|
|
|