Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K965254
Device Classification Name
Hearing Aid, Air Conduction
More FDA Info for this Device
510(K) Number
K965254
Device Name
Hearing Aid, Air Conduction
Applicant
WIDEX HEARING AID CO., INC.
35-53 24TH ST.
LONG ISLAND CITY, NY 11106 US
Other 510(k) Applications for this Company
Contact
RON MELTSNER
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
12/30/1996
Decision Date
03/12/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact