The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Sears Model Lm9091 In-the-ear Hearing Instrument.
Device ID | K901388 |
510k Number | K901388 |
Device Name: | SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT |
Classification | Hearing Aid, Air Conduction |
Applicant | MIRACLE-EAR, INC. 7731 COUNTRY CLUB DR. Golden Valley, MN 55427 |
Contact | Kevin Kutina |
Correspondent | Kevin Kutina MIRACLE-EAR, INC. 7731 COUNTRY CLUB DR. Golden Valley, MN 55427 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-26 |
Decision Date | 1990-04-16 |