The following data is part of a premarket notification filed by Happersberger Otopront Gmbh with the FDA for Langgasse 90.
| Device ID | K932470 |
| 510k Number | K932470 |
| Device Name: | LANGGASSE 90 |
| Classification | Unit, Examining/treatment, Ent |
| Applicant | HAPPERSBERGER OTOPRONT GMBH D-6209 HOHENSTEIN 1 P.O. BOX Germany, GR |
| Contact | Marc Strelow |
| Correspondent | Marc Strelow HAPPERSBERGER OTOPRONT GMBH D-6209 HOHENSTEIN 1 P.O. BOX Germany, GR |
| Product Code | ETF |
| CFR Regulation Number | 874.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-20 |
| Decision Date | 1993-08-25 |