The following data is part of a premarket notification filed by Nidacon International Ab with the FDA for Proinsert.
| Device ID | K131145 |
| 510k Number | K131145 |
| Device Name: | PROINSERT |
| Classification | Labware, Assisted Reproduction |
| Applicant | NIDACON INTERNATIONAL AB 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm NIDACON INTERNATIONAL AB 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2014-02-20 |
| Summary: | summary |