The following data is part of a premarket notification filed by Medlogic Global Ltd. with the FDA for Liquiband Ultima, Model Lb0004.
| Device ID | K083531 |
| 510k Number | K083531 |
| Device Name: | LIQUIBAND ULTIMA, MODEL LB0004 |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | MEDLOGIC GLOBAL LTD. 5353 WAYZATA BLVD., SUITE 505 Minneapolis, MN 55416 |
| Contact | Tierney Norsted |
| Correspondent | Tierney Norsted MEDLOGIC GLOBAL LTD. 5353 WAYZATA BLVD., SUITE 505 Minneapolis, MN 55416 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-28 |
| Decision Date | 2009-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05036912000871 | K083531 | 000 |