The following data is part of a premarket notification filed by Lexion Medical Llc with the FDA for Ap50/30 Insufflator With Insuflow Port.
| Device ID | K191780 |
| 510k Number | K191780 |
| Device Name: | AP50/30 Insufflator With Insuflow Port |
| Classification | Insufflator, Laparoscopic |
| Applicant | Lexion Medical LLC 545 Atwater Circle St Paul, MN 55103 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath HRG 4486 Timberline Ct Vadnais Heights, MN 55127 |
| Product Code | HIF |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | OSV |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-02 |
| Decision Date | 2019-08-28 |