The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Intra Ii Secret Ear Hearing Aids Ise.
| Device ID | K880335 |
| 510k Number | K880335 |
| Device Name: | INTRA II SECRET EAR HEARING AIDS ISE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
| Contact | Keith Guggenberger |
| Correspondent | Keith Guggenberger STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-03-18 |