The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for Aquilex Fluid Control System H112.
| Device ID | K112642 |
| 510k Number | K112642 |
| Device Name: | AQUILEX FLUID CONTROL SYSTEM H112 |
| Classification | Insufflator, Hysteroscopic |
| Applicant | W.O.M. WORLD OF MEDICINE AG 1480 CAMBRIDGE STREET Cambridge, MA 02139 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab W.O.M. WORLD OF MEDICINE AG 1480 CAMBRIDGE STREET Cambridge, MA 02139 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-12 |
| Decision Date | 2012-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702002244 | K112642 | 000 |
| 04056702002190 | K112642 | 000 |
| 04056702002152 | K112642 | 000 |
| 04056702002145 | K112642 | 000 |
| 04056702002121 | K112642 | 000 |