Cleared Traditional

SLIVASURE

K051409 · Scandinavian Formulas, Inc. · Pathology
Aug 2005
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K051409 is an FDA 510(k) clearance for the SLIVASURE, a Stains, Chemical Solution (Class I — General Controls, product code LED), submitted by Scandinavian Formulas, Inc. (Sellersville, US). The FDA issued a Cleared decision on August 8, 2005, 69 days after receiving the submission on May 31, 2005. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K051409 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2005
Decision Date August 08, 2005
Days to Decision 69 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement

Device Classification

Product Code LED — Stains, Chemical Solution
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850