The following data is part of a premarket notification filed by Vena Group, Llc with the FDA for Venaone.
Device ID | K200285 |
510k Number | K200285 |
Device Name: | VenaOne |
Classification | Sleeve, Limb, Compressible |
Applicant | Vena Group, LLC 10 Westelm Gardens San Antonio, TX 78230 |
Contact | Kasey Vukson |
Correspondent | Bill Quanqin Dai JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine, CA 92620 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-02-05 |
Decision Date | 2020-07-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00194832000366 | K200285 | 000 |
00194832000373 | K200285 | 000 |
10194832000349 | K200285 | 000 |
00194832000205 | K200285 | 000 |
10194832000196 | K200285 | 000 |
00194832000144 | K200285 | 000 |
00194832000175 | K200285 | 000 |
10194832000110 | K200285 | 000 |
00194832000106 | K200285 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VENAONE 88726220 not registered Live/Pending |
Vena Group, LLC 2019-12-13 |