Cleared Traditional

LiquiBand Plus

K183570 · Advanced Medical Solutions Limited · General & Plastic Surgery
Mar 2020
Decision
444d
Days
Class 2
Risk

About This 510(k) Submission

K183570 is an FDA 510(k) clearance for the LiquiBand Plus, a Tissue Adhesive For The Topical Approximation Of Skin (Class II — Special Controls, product code MPN), submitted by Advanced Medical Solutions Limited (Plymouth, GB). The FDA issued a Cleared decision on March 9, 2020, 444 days after receiving the submission on December 21, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4010.

Submission Details

510(k) Number K183570 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2018
Decision Date March 09, 2020
Days to Decision 444 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MPN — Tissue Adhesive For The Topical Approximation Of Skin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4010
Definition Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k).

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