The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Sears Model 9098 Ite Hearing Aid.
Device ID | K901351 |
510k Number | K901351 |
Device Name: | SEARS MODEL 9098 ITE HEARING AID |
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 | 1990-03-23 |
Decision Date | 1990-04-27 |