The following data is part of a premarket notification filed by Clinical Innovations, Llc with the FDA for Ebb Complete Tamponade System.
| Device ID | K153591 |
| 510k Number | K153591 |
| Device Name: | Ebb Complete Tamponade System |
| Classification | Intrauterine Tamponade Balloon |
| Applicant | CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH Murray, UT 84123 |
| Contact | Tom Haueter |
| Correspondent | Tom Haueter CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH Murray, UT 84123 |
| Product Code | OQY |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-16 |
| Decision Date | 2016-01-14 |
| Summary: | summary |