The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Monopolar Attachment For Helix Hydro-jet, Model P/n 20139-094.
| Device ID | K062712 |
| 510k Number | K062712 |
| Device Name: | ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2007-01-26 |
| Summary: | summary |