The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Fluent Fluid Management System.
| Device ID | K180825 |
| 510k Number | K180825 |
| Device Name: | Fluent Fluid Management System |
| Classification | Insufflator, Hysteroscopic |
| Applicant | Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 |
| Contact | Christine Cameron |
| Correspondent | Christine Cameron Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045508552 | K180825 | 000 |
| 15420045507401 | K180825 | 000 |
| 45420045507662 | K180825 | 000 |
| 45420045505279 | K180825 | 000 |