The following data is part of a premarket notification filed by Lexion Medical, Llc. with the FDA for Pneuview Xe Veryclear Gas Evacuation Cannula.
| Device ID | K132203 |
| 510k Number | K132203 |
| Device Name: | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA |
| Classification | Insufflator, Laparoscopic |
| Applicant | LEXION MEDICAL, LLC. 4486 TIMBERLINE CT Vadnais Heights, MN 55127 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath LEXION MEDICAL, LLC. 4486 TIMBERLINE CT Vadnais Heights, MN 55127 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-16 |
| Decision Date | 2013-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852588007069 | K132203 | 000 |