The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Helix Hydro-jet.
| Device ID | K033590 |
| 510k Number | K033590 |
| Device Name: | ERBE HELIX HYDRO-JET |
| Classification | Lavage, Jet |
| Applicant | ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067 |
| Contact | John Tartal |
| Correspondent | John Tartal ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-10 |
| Decision Date | 2004-01-30 |
| Summary: | summary |