The following data is part of a premarket notification filed by Boston Surgical Products, Inc. with the FDA for Model 50 Bipolar Coagulator.
| Device ID | K972350 |
| 510k Number | K972350 |
| Device Name: | MODEL 50 BIPOLAR COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOSTON SURGICAL PRODUCTS, INC. 17 OLD COUNTRY RD. Oxford, CT 06478 -1715 |
| Contact | Charles Vassallo |
| Correspondent | Charles Vassallo BOSTON SURGICAL PRODUCTS, INC. 17 OLD COUNTRY RD. Oxford, CT 06478 -1715 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-24 |
| Decision Date | 1997-08-21 |
| Summary: | summary |