The following data is part of a premarket notification filed by Medlogic Global Limited with the FDA for Liquiband Ultima, Lut 003.
Device ID | K100284 |
510k Number | K100284 |
Device Name: | LIQUIBAND ULTIMA, LUT 003 |
Classification | Tissue Adhesive For The Topical Approximation Of Skin |
Applicant | MEDLOGIC GLOBAL LIMITED WESTERN WOOD WAY LANGAGE SCIENCE PARK Plymouth, Devon, GB Pl7 5bg |
Contact | Michael Browne |
Correspondent | Michael Browne MEDLOGIC GLOBAL LIMITED WESTERN WOOD WAY LANGAGE SCIENCE PARK Plymouth, Devon, GB Pl7 5bg |
Product Code | MPN |
CFR Regulation Number | 878.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-02-01 |
Decision Date | 2010-04-09 |
Summary: | summary |