The following data is part of a premarket notification filed by Faulhaber Pinzetten Ohg with the FDA for Single-use Non-stick Bipolar Forceps Bayonet, Single-use Non-stick Bipolar Irrigating Forceps, Single Use Non-stick Bipolar Suction Forceps.
| Device ID | K182773 |
| 510k Number | K182773 |
| Device Name: | Single-Use Non-Stick Bipolar Forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating Forceps, Single Use Non-Stick Bipolar Suction Forceps |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Faulhaber Pinzetten OHG Daimlerstr. 1 Frittlingen, DE 78665 |
| Contact | Dorothea Faulhaber |
| Correspondent | Dorothea Faulhaber Faulhaber Pinzetten OHG Daimlerstr. 1 Frittlingen, DE 78665 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-01 |
| Decision Date | 2019-10-08 |
| Summary: | summary |