The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Waterjet Model Erbejet® 2 System With Hybridapc Probe.
| Device ID | K143306 |
| 510k Number | K143306 |
| Device Name: | ERBE WaterJet Model ERBEJET® 2 System With HybridAPC Probe |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 2225 NORTHWEST PARKWAY Marietta, GA 30067 |
| Contact | John Tartal |
| Correspondent | John Tartal ERBE USA, INC. 2225 NORTHWEST PARKWAY Marietta, GA 30067 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-18 |
| Decision Date | 2015-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147020108 | K143306 | 000 |