The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Instant Fit Custom Earmold.
| Device ID | K870985 |
| 510k Number | K870985 |
| Device Name: | 3M INSTANT FIT CUSTOM EARMOLD |
| Classification | Hearing Aid, Air Conduction |
| Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Contact | Deanna Oliveira |
| Correspondent | Deanna Oliveira 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-11 |
| Decision Date | 1987-03-30 |