The following data is part of a premarket notification filed by United Hearing Systems, Inc. with the FDA for Phonic Ear Ite/itc Hrng Aid 901, 902, 903, 906,911.
| Device ID | K892803 |
| 510k Number | K892803 |
| Device Name: | PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | UNITED HEARING SYSTEMS, INC. P.O BOX 122 731B NORWICH ROAD Plainfield, CT 06374 |
| Contact | Ralph Campagna |
| Correspondent | Ralph Campagna UNITED HEARING SYSTEMS, INC. P.O BOX 122 731B NORWICH ROAD Plainfield, CT 06374 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-17 |
| Decision Date | 1989-06-22 |