The following data is part of a premarket notification filed by Kli with the FDA for One Incision Bi-polar Electro. Forceps.
| Device ID | K781089 |
| 510k Number | K781089 |
| Device Name: | ONE INCISION BI-POLAR ELECTRO. FORCEPS |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | KLI 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-29 |
| Decision Date | 1978-07-17 |