The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Erbejet 2 System.
| Device ID | K072404 |
| 510k Number | K072404 |
| Device Name: | ERBE ERBEJET 2 SYSTEM |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-27 |
| Decision Date | 2007-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147019683 | K072404 | 000 |
| 04050147000322 | K072404 | 000 |
| 04050147015418 | K072404 | 000 |
| 04050147015425 | K072404 | 000 |
| 04050147015432 | K072404 | 000 |
| 04050147015449 | K072404 | 000 |
| 04050147015456 | K072404 | 000 |
| 04050147015463 | K072404 | 000 |
| 04050147015470 | K072404 | 000 |
| 04050147015371 | K072404 | 000 |
| 04050147018327 | K072404 | 000 |
| 04050147019263 | K072404 | 000 |
| 04050147019676 | K072404 | 000 |
| 04050147000261 | K072404 | 000 |