The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Softline Spring Clip.
| Device ID | K000098 |
| 510k Number | K000098 |
| Device Name: | SOFTLINE SPRING CLIP |
| 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 | 2000-01-13 |
| Decision Date | 2000-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852621004765 | K000098 | 000 |
| 10852621004755 | K000098 | 000 |
| 00852621004741 | K000098 | 000 |
| 00852621004734 | K000098 | 000 |
| 00852621004048 | K000098 | 000 |
| 00852621004031 | K000098 | 000 |
| 00852621004024 | K000098 | 000 |
| 10852621004014 | K000098 | 000 |