The following data is part of a premarket notification filed by Medtrex, Inc. with the FDA for Encore Electrosurgical Handcontrol Pencil (35001-001).
| Device ID | K970039 |
| 510k Number | K970039 |
| Device Name: | ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTREX, INC. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Contact | William E Mckay |
| Correspondent | William E Mckay MEDTREX, INC. 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-06 |
| Decision Date | 1997-02-26 |