The following data is part of a premarket notification filed by Sound Crafters Hearing Instruments with the FDA for Hearing Aid (all In The Ear).
| Device ID | K872995 |
| 510k Number | K872995 |
| Device Name: | HEARING AID (ALL IN THE EAR) |
| Classification | Hearing Aid, Air Conduction |
| Applicant | SOUND CRAFTERS HEARING INSTRUMENTS 6100 MARTWAY Mission, KS 66202 |
| Contact | Oscar Casselman |
| Correspondent | Oscar Casselman SOUND CRAFTERS HEARING INSTRUMENTS 6100 MARTWAY Mission, KS 66202 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-31 |
| Decision Date | 1987-09-16 |