The following data is part of a premarket notification filed by Medical And Scientific Enterprises, Inc. with the FDA for Endostat Electrosurgical Unit.
| Device ID | K913881 |
| 510k Number | K913881 |
| Device Name: | ENDOSTAT ELECTROSURGICAL UNIT |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | MEDICAL AND SCIENTIFIC ENTERPRISES, INC. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | Llynne Aronson |
| Correspondent | Llynne Aronson MEDICAL AND SCIENTIFIC ENTERPRISES, INC. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-29 |
| Decision Date | 1991-11-01 |