The following data is part of a premarket notification filed by Ujenzi Charitable Trust with the FDA for Every Second Matters-uterine Balloon Tamponade (“esm-ubt”).
| Device ID | K191264 |
| 510k Number | K191264 |
| Device Name: | Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) |
| Classification | Intrauterine Tamponade Balloon |
| Applicant | Ujenzi Charitable Trust 22 Welgate Road Medford, MA 02155 |
| Contact | Thomas Burke |
| Correspondent | Jonathan S. Kahan Hogan Lovells US LLP 555 13th St. NW Washington, DC 20004 |
| Product Code | OQY |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-10 |
| Decision Date | 2019-10-30 |
| Summary: | summary |