The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg with the FDA for Stryker Bipolar Forceps.
| Device ID | K093108 |
| 510k Number | K093108 |
| Device Name: | STRYKER BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Stryker Leibinger GmbH & Co. KG 750 TRADE CENTRE WAY SUITE 200 Portage, MI 49002 |
| Contact | Rob Yamashita |
| Correspondent | Rob Yamashita Stryker Leibinger GmbH & Co. KG 750 TRADE CENTRE WAY SUITE 200 Portage, MI 49002 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-06-22 |
| Summary: | summary |