The following data is part of a premarket notification filed by Dmc Medical Ltd. with the FDA for Dmc Saphenous Vein Distention System (svds).
| Device ID | K000704 |
| 510k Number | K000704 |
| Device Name: | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) |
| Classification | Catheter, Irrigation |
| Applicant | DMC MEDICAL LTD. 511 CATALINA RD. Fullerton, CA 92835 |
| Contact | Charmaine Henderson |
| Correspondent | Charmaine Henderson DMC MEDICAL LTD. 511 CATALINA RD. Fullerton, CA 92835 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-02 |
| Decision Date | 2000-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530750110 | K000704 | 000 |
| 05391530750080 | K000704 | 000 |
| 05391530750059 | K000704 | 000 |