Device Classification Name |
Hearing Aid, Air Conduction
More FDA Info for this Device |
510(K) Number |
K961622 |
Device Name |
Hearing Aid, Air Conduction |
Applicant |
PHONAK, INC.
850 E. DIEHL RD.
BOX 3117
NAPERVILLE, IL 60566 US
Other 510(k) Applications for this Company
|
Contact |
FRANCIS K KUK, PH.D.,CCC-A
Other 510(k) Applications for this Contact |
Regulation Number |
874.3300
More FDA Info for this Regulation Number |
Classification Product Code |
ESD
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/26/1996 |
Decision Date |
05/17/1996 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
EN - Ear, Nose, & Throat |
Review Advisory Committee |
EN - Ear, Nose, & Throat |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|