The following data is part of a premarket notification filed by Aspen Labs with the FDA for Single Use Laparscopic Electrode.
| Device ID | K904240 |
| 510k Number | K904240 |
| Device Name: | SINGLE USE LAPARSCOPIC ELECTRODE |
| Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Applicant | ASPEN LABS 310 BROAD ST. Utica, NY 13501 |
| Contact | Jane Johnson |
| Correspondent | Jane Johnson ASPEN LABS 310 BROAD ST. Utica, NY 13501 |
| Product Code | HFG |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-13 |
| Decision Date | 1991-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405034831 | K904240 | 000 |
| 20653405009662 | K904240 | 000 |
| 20653405009679 | K904240 | 000 |
| 20653405009686 | K904240 | 000 |
| 20653405009747 | K904240 | 000 |
| 20653405009761 | K904240 | 000 |
| 20653405009778 | K904240 | 000 |
| 20653405009785 | K904240 | 000 |
| 20653405009792 | K904240 | 000 |
| 20653405034442 | K904240 | 000 |
| 20653405034787 | K904240 | 000 |
| 20653405034800 | K904240 | 000 |
| 20653405009655 | K904240 | 000 |