The following data is part of a premarket notification filed by Endoscopic Concepts, Inc. with the FDA for Sabre Bt Blunt0tip Surgical Trocar.
| Device ID | K980804 |
| 510k Number | K980804 |
| Device Name: | SABRE BT BLUNT0TIP SURGICAL TROCAR |
| Classification | Trocar, Gastro-urology |
| Applicant | ENDOSCOPIC CONCEPTS, INC. 50 BREWSTER ST. Pawtucket, RI 02860 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau ENDOSCOPIC CONCEPTS, INC. 50 BREWSTER ST. Pawtucket, RI 02860 |
| Product Code | FBQ |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-04-01 |
| Summary: | summary |