The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Includer Clamp.
| Device ID | K010694 |
| 510k Number | K010694 |
| Device Name: | INCLUDER CLAMP |
| Classification | Clamp, Vascular |
| Applicant | NOVARE SURGICAL SYSTEMS, INC. 10231 BUBB RD. Cupertino, CA 95014 |
| Contact | Terry Buelna |
| Correspondent | Terry Buelna NOVARE SURGICAL SYSTEMS, INC. 10231 BUBB RD. Cupertino, CA 95014 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-08 |
| Decision Date | 2002-02-11 |