The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for 40 L High Flow Insufflator F108.
| Device ID | K030837 |
| 510k Number | K030837 |
| Device Name: | 40 L HIGH FLOW INSUFFLATOR F108 |
| Classification | Insufflator, Laparoscopic |
| Applicant | W.O.M. WORLD OF MEDICINE AG 368 NORTH ASAPH STREET Alexandria, VA 22314 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab W.O.M. WORLD OF MEDICINE AG 368 NORTH ASAPH STREET Alexandria, VA 22314 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-17 |
| Decision Date | 2004-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702003203 | K030837 | 000 |
| 04056702000059 | K030837 | 000 |
| 10888867100845 | K030837 | 000 |
| 04056702000011 | K030837 | 000 |
| 00888867100817 | K030837 | 000 |
| 00888867100848 | K030837 | 000 |
| 00888867207950 | K030837 | 000 |