The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for Iur Fluid Management System.
| Device ID | K031616 |
| 510k Number | K031616 |
| Device Name: | IUR FLUID MANAGEMENT SYSTEM |
| Classification | Insufflator, Hysteroscopic |
| Applicant | W.O.M. WORLD OF MEDICINE AG 320 NORTH COLUMBUS ST. Alexandria, VA 22314 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab W.O.M. WORLD OF MEDICINE AG 320 NORTH COLUMBUS ST. Alexandria, VA 22314 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-23 |
| Decision Date | 2003-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556570517 | K031616 | 000 |
| 03596010654885 | K031616 | 000 |
| 03596010529497 | K031616 | 000 |
| 03596010529541 | K031616 | 000 |
| 23596010529507 | K031616 | 000 |
| 23596010529514 | K031616 | 000 |
| 03596010529534 | K031616 | 000 |
| 03596010529558 | K031616 | 000 |
| 00885556570487 | K031616 | 000 |
| 00885556570494 | K031616 | 000 |
| 20884521744063 | K031616 | 000 |