The following data is part of a premarket notification filed by Boston Surgical Products, Inc. with the FDA for Disposable & Reusable Surgical Cutting Tools.
| Device ID | K953012 |
| 510k Number | K953012 |
| Device Name: | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| 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 | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-28 |
| Decision Date | 1995-07-12 |