The following data is part of a premarket notification filed by Alydia Health with the FDA for Jada System.
| Device ID | K212757 |
| 510k Number | K212757 |
| Device Name: | Jada System |
| Classification | Intrauterine Tamponade Balloon |
| Applicant | Alydia Health 3495 Edison Way Menlo Park, CA 94025 |
| Contact | Colby Holtshouse |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010 |
| Product Code | OQY |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-31 |
| Decision Date | 2021-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60840164521131 | K212757 | 000 |