The following data is part of a premarket notification filed by Owandy with the FDA for Visteo.
Device ID | K093105 |
510k Number | K093105 |
Device Name: | VISTEO |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | OWANDY 845 ARONSON LAKE COURT Roswell, GA 30075 |
Contact | Jay Mansour |
Correspondent | Jay Mansour OWANDY 845 ARONSON LAKE COURT Roswell, GA 30075 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-01 |
Decision Date | 2010-10-18 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VISTEO 78775453 not registered Dead/Abandoned |
Harmonic, Inc. 2005-12-16 |