The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Modification To: Erbe Apc Connector Hose And Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166.
| Device ID | K013348 |
| 510k Number | K013348 |
| Device Name: | MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-09 |
| Decision Date | 2001-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147015043 | K013348 | 000 |
| 04050147015029 | K013348 | 000 |
| 04050147017337 | K013348 | 000 |
| 04050147015005 | K013348 | 000 |
| 04050147017160 | K013348 | 000 |
| 04050147001145 | K013348 | 000 |
| 04050147014992 | K013348 | 000 |
| 04050147014718 | K013348 | 000 |