The following data is part of a premarket notification filed by Bt Medical Co., Inc. with the FDA for Ureteral Compression Device.
| Device ID | K931268 |
| 510k Number | K931268 |
| Device Name: | URETERAL COMPRESSION DEVICE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | BT MEDICAL CO., INC. SECOND AND DEPOT Bridgeport, PA 19405 |
| Contact | Buckley Thompson |
| Correspondent | Buckley Thompson BT MEDICAL CO., INC. SECOND AND DEPOT Bridgeport, PA 19405 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1993-07-19 |