The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for Hystereoscopy Pump Hm4.
| Device ID | K022449 |
| 510k Number | K022449 |
| Device Name: | HYSTEREOSCOPY PUMP HM4 |
| Classification | Insufflator, Hysteroscopic |
| Applicant | W.O.M. WORLD OF MEDICINE AG 91 TROWBRIDGE ST. Cambridge, MA 02138 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab W.O.M. WORLD OF MEDICINE AG 91 TROWBRIDGE ST. Cambridge, MA 02138 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-26 |
| Decision Date | 2003-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702004507 | K022449 | 000 |
| 04056702004484 | K022449 | 000 |
| 04056702002534 | K022449 | 000 |
| 04056702002367 | K022449 | 000 |
| 04056702002329 | K022449 | 000 |
| 04056702000783 | K022449 | 000 |
| 04056702000769 | K022449 | 000 |
| 04056702000097 | K022449 | 000 |