The following data is part of a premarket notification filed by Agency For Medical Innovations Gmbh with the FDA for More-cell-system.
| Device ID | K212659 |
| 510k Number | K212659 |
| Device Name: | More-Cell-System |
| Classification | Containment System, Laparoscopic Power Morcellation, With Instrument Port |
| Applicant | Agency For Medical Innovations GmbH Im Letten 1 Feldkirch, AT 6800 |
| Contact | Martin Hohlrieder |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110 |
| Product Code | PMU |
| CFR Regulation Number | 884.4050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2021-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| MCS55511 | K212659 | 000 |
| EAMIMCS55311 | K212659 | 000 |
| EAMIMCS55110 | K212659 | 000 |