The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Hybrid Knife.
| Device ID | K083608 |
| 510k Number | K083608 |
| Device Name: | ERBE HYBRID KNIFE |
| 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 | 2008-12-05 |
| Decision Date | 2009-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147018358 | K083608 | 000 |
| 04050147018341 | K083608 | 000 |