INSUFLOW
Insufflator, Laparoscopic
LEXION MEDICAL, LLC.
The following data is part of a premarket notification filed by Lexion Medical, Llc. with the FDA for Insuflow.
Pre-market Notification Details
| Device ID | K090456 |
| 510k Number | K090456 |
| Device Name: | INSUFLOW |
| Classification | Insufflator, Laparoscopic |
| Applicant | LEXION MEDICAL, LLC. 5000 TOWNSHIP PKWY St. Paul, MN 55110 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath LEXION MEDICAL, LLC. 5000 TOWNSHIP PKWY St. Paul, MN 55110 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-23 |
| Decision Date | 2009-08-26 |
| Summary: | summary |
Trademark Results [INSUFLOW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSUFLOW 76692360 3600784 Dead/Cancelled |
Georgia Biomedical, Inc. 2008-08-25 |
 INSUFLOW 75267363 2202184 Dead/Cancelled |
Georgia BioMedical, Inc. 1997-04-01 |
 INSUFLOW 74246848 not registered Dead/Abandoned |
Georgia Biomedical, Inc. 1992-02-18 |
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