The following data is part of a premarket notification filed by W.o.m World Of Medicine Gmbh with the FDA for Insufflator 50l Fm134.
| Device ID | K153513 |
| 510k Number | K153513 |
| Device Name: | Insufflator 50L FM134 |
| Classification | Insufflator, Laparoscopic |
| Applicant | W.O.M WORLD OF MEDICINE GMBH SALZUFER 8 Berlin, DE 10587 |
| Contact | Soeren Markworth |
| Correspondent | Susanne Raab Susanne Raab 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 | 2015-12-07 |
| Decision Date | 2016-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702005771 | K153513 | 000 |
| 04056702008802 | K153513 | 000 |
| 04056702008895 | K153513 | 000 |
| 04056702007218 | K153513 | 000 |
| 04056702007379 | K153513 | 000 |
| 04056702007430 | K153513 | 000 |
| 04056702000721 | K153513 | 000 |
| 04056702002602 | K153513 | 000 |
| 04056702002633 | K153513 | 000 |
| 04056702002824 | K153513 | 000 |
| 04056702002831 | K153513 | 000 |
| 04056702003227 | K153513 | 000 |
| 04056702008789 | K153513 | 000 |