The following data is part of a premarket notification filed by Boston Surgical Products, Inc. with the FDA for Bipolar Electrosurgical Pencil.
| Device ID | K943031 |
| 510k Number | K943031 |
| Device Name: | BIPOLAR ELECTROSURGICAL PENCIL |
| Classification | Unit, Cautery, Thermal, Ac-powered |
| Applicant | BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston, MA 02364 |
| Contact | Lawrence T Kirwan |
| Correspondent | Lawrence T Kirwan BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston, MA 02364 |
| Product Code | HQO |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-27 |
| Decision Date | 1994-09-23 |