The following data is part of a premarket notification filed by Medical And Scientific Enterprises, Inc. with the FDA for Bistat 70/70-i Electrosurgical Unit.
| Device ID | K933131 |
| 510k Number | K933131 |
| Device Name: | BISTAT 70/70-I ELECTROSURGICAL UNIT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDICAL AND SCIENTIFIC ENTERPRISES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara |
| Correspondent | Mary Mcnamara MEDICAL AND SCIENTIFIC ENTERPRISES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-28 |
| Decision Date | 1994-02-15 |