The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Faceplate, Custom In-the-ear Hearing Aid, Fpr.
| Device ID | K862769 |
| 510k Number | K862769 |
| Device Name: | FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR |
| Classification | Face Plate Hearing Aid |
| Applicant | MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
| Contact | Paul M D'amico |
| Correspondent | Paul M D'amico MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
| Product Code | LRB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-22 |
| Decision Date | 1986-08-13 |