The following data is part of a premarket notification filed by Medicamat S.a. with the FDA for B.u.s. Endotron.
| Device ID | K972148 |
| 510k Number | K972148 |
| Device Name: | B.U.S. ENDOTRON |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | MEDICAMAT S.A. 1776 K STREET, N.W. Washington, DC 20006 |
| Contact | Andrew S Krulwich |
| Correspondent | Andrew S Krulwich MEDICAMAT S.A. 1776 K STREET, N.W. Washington, DC 20006 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-12-10 |