The following data is part of a premarket notification filed by Boston Surgical Products, Inc. with the FDA for Disposable & Reusable Monopolar Handswithc Pencil.
| Device ID | K951269 |
| 510k Number | K951269 |
| Device Name: | DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston, MA 02364 |
| Contact | Lawrence T Kirwan, Jr. |
| Correspondent | Lawrence T Kirwan, Jr. BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston, MA 02364 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-21 |
| Decision Date | 1995-04-24 |