The following data is part of a premarket notification filed by Vivant Medical, Inc. with the FDA for Vivawave Microwave System.
| Device ID | K011676 |
| 510k Number | K011676 |
| Device Name: | VIVAWAVE MICROWAVE SYSTEM |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Contact | Steven Kim |
| Correspondent | Steven Kim VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-30 |
| Decision Date | 2002-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524002538 | K011676 | 000 |
| 10884524001722 | K011676 | 000 |
| 10884524002583 | K011676 | 000 |
| 10884524001579 | K011676 | 000 |