IN THE EAR HEARING AID— 510(k) K964898

Substantially Equivalent

Keytone Hearing Laboratory

FDA 510(k) clearance K964898 for IN THE EAR HEARING AID, Substantially Equivalent on 1997-04-21. Applicant: Keytone Hearing Laboratory. Device class: 1.

Clearance details

Applicant
Keytone Hearing Laboratory
Product code
Code ESD
Device class
Class 1
Regulation
21 CFR 874.3300
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Little Rock, AR, US
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