The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for 45l Core Insufflator, Model F114.
| Device ID | K063367 |
| 510k Number | K063367 |
| Device Name: | 45L CORE INSUFFLATOR, MODEL F114 |
| Classification | Insufflator, Laparoscopic |
| 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 | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-07 |
| Decision Date | 2007-05-23 |
| Summary: | summary |