The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Bipolar Pencil, Model 3901-002, 3900-002.
| Device ID | K010487 |
| 510k Number | K010487 |
| Device Name: | BIPOLAR PENCIL, MODEL 3901-002, 3900-002 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Contact | Janet Mcauley |
| Correspondent | Janet Mcauley MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-20 |
| Decision Date | 2001-05-03 |