The following data is part of a premarket notification filed by Lexion Medical, Llc. with the FDA for Vasovapor.
Device ID | K101320 |
510k Number | K101320 |
Device Name: | VASOVAPOR |
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 | 2010-05-11 |
Decision Date | 2010-06-24 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VASOVAPOR 76700590 not registered Dead/Abandoned |
Lexion Medical, LLC 2009-11-27 |