The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Bipolar Endostasis Probe, Best (tm).
| Device ID | K915408 |
| 510k Number | K915408 |
| Device Name: | BIPOLAR ENDOSTASIS PROBE, BEST (TM) |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Contact | Samuel Dickstein |
| Correspondent | Samuel Dickstein MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-02 |
| Decision Date | 1992-03-11 |