Cleared Traditional

DYNACOR LUBRICATION GEL

K103718 · Medline Industries, Inc. · General Hospital
May 2011
Decision
140d
Days
Class 1
Risk

About This 510(k) Submission

K103718 is an FDA 510(k) clearance for the DYNACOR LUBRICATION GEL, a Lubricant, Patient (Class I — General Controls, product code KMJ), submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on May 10, 2011, 140 days after receiving the submission on December 21, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K103718 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2010
Decision Date May 10, 2011
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KMJ — Lubricant, Patient
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6375

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