The following data is part of a premarket notification filed by Lexion Medical Llc with the FDA for Ap 50/30 Insufflator With Insuflow Port.
| Device ID | K170799 |
| 510k Number | K170799 |
| Device Name: | AP 50/30 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 | 2017-03-17 |
| Decision Date | 2017-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852588007229 | K170799 | 000 |