The following data is part of a premarket notification filed by Medlogic Global Limited with the FDA for Liquishield-s (0.7g), Model Ls 0010, Liquishield-s (2.0g), Model Ls 0020.
Device ID | K023163 |
510k Number | K023163 |
Device Name: | LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020 |
Classification | Bandage, Liquid |
Applicant | MEDLOGIC GLOBAL LIMITED WESTERN WOOD WAY LANGAGE SCIENCE PARK Plymouth, Devon, GB Pl7 5bg |
Contact | Howard Beaumont |
Correspondent | Howard Beaumont MEDLOGIC GLOBAL LIMITED WESTERN WOOD WAY LANGAGE SCIENCE PARK Plymouth, Devon, GB Pl7 5bg |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-23 |
Decision Date | 2003-01-13 |
Summary: | summary |