The following data is part of a premarket notification filed by Materna Medical with the FDA for Milli Vaginal Dilator.
| Device ID | K211959 |
| 510k Number | K211959 |
| Device Name: | Milli Vaginal Dilator |
| Classification | Dilator, Vaginal |
| Applicant | Materna Medical 2495 Hospital Drive Suite 300 Mountain View, CA 94040 |
| Contact | Kelly Ashfield |
| Correspondent | Valerie Defiesta-ng Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
| Product Code | HDX |
| CFR Regulation Number | 884.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-24 |
| Decision Date | 2021-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195893413942 | K211959 | 000 |