The following data is part of a premarket notification filed by Hyunjae Corp. with the FDA for Hyunjae Corporation - Nusil Earmold Impression Material.
| Device ID | K973927 |
| 510k Number | K973927 |
| Device Name: | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | HYUNJAE CORP. 8 SOUTH END PLAZA New Milford, CT 06776 |
| Contact | Dan Modica |
| Correspondent | Dan Modica HYUNJAE CORP. 8 SOUTH END PLAZA New Milford, CT 06776 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-15 |
| Decision Date | 1997-12-11 |