The following data is part of a premarket notification filed by W.o.m. World Of Medicine Gmbh with the FDA for Gyn-pump Ph304.
| Device ID | K173489 |
| 510k Number | K173489 |
| Device Name: | GYN-Pump PH304 |
| Classification | Insufflator, Hysteroscopic |
| Applicant | W.O.M. World Of Medicine GmbH Salzufer 8 Berlin, DE 10587 |
| Contact | Soeren Markworth |
| Correspondent | Soeren Markworth W.O.M. World Of Medicine GmbH Salzufer 8 Berlin, DE 10587 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702006273 | K173489 | 000 |
| 04056702008864 | K173489 | 000 |
| 04056702008888 | K173489 | 000 |
| 04056702004705 | K173489 | 000 |
| 04056702005368 | K173489 | 000 |
| 04056702005382 | K173489 | 000 |
| 04056702005412 | K173489 | 000 |
| 04056702005436 | K173489 | 000 |
| 04056702005672 | K173489 | 000 |
| 04056702005689 | K173489 | 000 |
| 04056702005795 | K173489 | 000 |
| 04056702005825 | K173489 | 000 |
| 04056702008840 | K173489 | 000 |