The following data is part of a premarket notification filed by Ug Global Resources Sdn Bhd with the FDA for Lano-e.
Device ID | K111718 |
510k Number | K111718 |
Device Name: | LANO-E |
Classification | Polymer Patient Examination Glove |
Applicant | UG GLOBAL RESOURCES SDN BHD 1565 SUNFLOWER AVE. Costa Mesa, CA 92626 |
Contact | Kenneth Stanton |
Correspondent | Kenneth Stanton UG GLOBAL RESOURCES SDN BHD 1565 SUNFLOWER AVE. Costa Mesa, CA 92626 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-20 |
Decision Date | 2012-06-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() LANO-E 77276892 3430616 Live/Registered |
UG Healthcare (USA), Inc. 2007-09-11 |