The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Dahlberg Model Lb Behind-the-ear Hearing Aid.
Device ID | K910809 |
510k Number | K910809 |
Device Name: | DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID |
Classification | Hearing Aid, Air Conduction |
Applicant | MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis, MN 55426 |
Contact | Kevin L Kutina |
Correspondent | Kevin L Kutina MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis, MN 55426 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-26 |
Decision Date | 1991-03-21 |