The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Apc Handle And Applicators, Model 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045.
| Device ID | K003462 |
| 510k Number | K003462 |
| Device Name: | ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 2275 NORTHWEST PKWY., STE. 105 Marietta, GA 30067 |
| Contact | John Tartal |
| Correspondent | John Tartal ERBE USA, INC. 2275 NORTHWEST PKWY., STE. 105 Marietta, GA 30067 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-07 |
| Decision Date | 2001-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147000773 | K003462 | 000 |
| 04050147000674 | K003462 | 000 |
| 04050147000650 | K003462 | 000 |
| 04050147000605 | K003462 | 000 |
| 04050147000599 | K003462 | 000 |
| 04050147000575 | K003462 | 000 |
| 04050147000551 | K003462 | 000 |
| 04050147000544 | K003462 | 000 |