The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Precise, Tynmpanette, And Xacto Impression Kits.
| Device ID | K964245 |
| 510k Number | K964245 |
| Device Name: | PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS |
| Classification | Hearing Aid, Air Conduction |
| Applicant | STARKEY LABORATORIES, INC. 6600-6700 WASHINGTON AVE.SOUTH Eden Prairie, MN 55344 |
| Contact | Shari L Swiden |
| Correspondent | Shari L Swiden STARKEY LABORATORIES, INC. 6600-6700 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 | 1996-10-24 |
| Decision Date | 1997-02-04 |
| Summary: | summary |