The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Bipolar Adapter Cable, Model 72200022.
| Device ID | K083528 |
| 510k Number | K083528 |
| Device Name: | SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SMITH & NEPHEW, INC. 1980 NONCONNAH BLVD Memphis, TN 38132 |
| Contact | Kim P Kelly |
| Correspondent | Kim P Kelly SMITH & NEPHEW, INC. 1980 NONCONNAH BLVD Memphis, TN 38132 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-28 |
| Decision Date | 2009-01-28 |
| Summary: | summary |