The following data is part of a premarket notification filed by W.o.m. World Of Medicine Gmbh with the FDA for Aquilex Fluid Control System Aql-100s.
| Device ID | K172040 |
| 510k Number | K172040 |
| Device Name: | Aquilex Fluid Control System AQL-100S |
| Classification | Insufflator, Hysteroscopic |
| Applicant | W.O.M. World Of Medicine GmbH Salzufer 8 Berlin, DE 10587 |
| Contact | Lucia Puetmann |
| Correspondent | Susanne Raab Susanne Raab Guenthersburgallee 75 Frankfurt, DE 60389 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2018-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702006914 | K172040 | 000 |
| 04056702006556 | K172040 | 000 |