The following data is part of a premarket notification filed by Cochlear Laboratories, Ltd. with the FDA for Custom In-the-ear And Canal Hearing Aid.
| Device ID | K862754 |
| 510k Number | K862754 |
| Device Name: | CUSTOM IN-THE-EAR AND CANAL HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | COCHLEAR LABORATORIES, LTD. P.O. BOX 20514 Bloomington, MN 55431 |
| Contact | Bruce Bullock |
| Correspondent | Bruce Bullock COCHLEAR LABORATORIES, LTD. P.O. BOX 20514 Bloomington, MN 55431 |
| Product Code | ESD |
| 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 | 1986-08-01 |