The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Codman Integrated Bipolar Cord And Tubing Set.
| Device ID | K163106 |
| 510k Number | K163106 |
| Device Name: | CODMAN Integrated Bipolar Cord And Tubing Set |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Megan Palumbo |
| Correspondent | Megan Palumbo Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-07 |
| Decision Date | 2016-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886704080531 | K163106 | 000 |
| 00381780521740 | K163106 | 000 |
| 00381780521757 | K163106 | 000 |
| 00381780521764 | K163106 | 000 |
| 00381780521771 | K163106 | 000 |
| 00381780521788 | K163106 | 000 |
| 20886704080487 | K163106 | 000 |
| 20886704080494 | K163106 | 000 |
| 20886704080500 | K163106 | 000 |
| 20886704080517 | K163106 | 000 |
| 20886704080524 | K163106 | 000 |
| 00381780521733 | K163106 | 000 |