The following data is part of a premarket notification filed by Neomed Corp. with the FDA for Tracor, Cannula, Bicepts Bipolar.
| Device ID | K790043 |
| 510k Number | K790043 |
| Device Name: | TRACOR, CANNULA, BICEPTS BIPOLAR |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | NEOMED CORP. 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 | 1979-01-05 |
| Decision Date | 1979-02-08 |