The following data is part of a premarket notification filed by Bob Bare Hearing Aid Repair with the FDA for Ahl, Ite Model American.
Device ID | K910325 |
510k Number | K910325 |
Device Name: | AHL, ITE MODEL AMERICAN |
Classification | Hearing Aid, Air Conduction |
Applicant | BOB BARE HEARING AID REPAIR 14232 MARSH LANE, SUITE 324 Dallas, TX 75234 |
Contact | Robert C Bare |
Correspondent | Robert C Bare BOB BARE HEARING AID REPAIR 14232 MARSH LANE, SUITE 324 Dallas, TX 75234 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-24 |
Decision Date | 1991-04-15 |