Cleared Traditional

DUKAL LUBRICATING JELLY

K113689 · Dukal Corporation · General Hospital
May 2012
Decision
141d
Days
Class 1
Risk

About This 510(k) Submission

K113689 is an FDA 510(k) clearance for the DUKAL LUBRICATING JELLY, a Lubricant, Patient (Class I — General Controls, product code KMJ), submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on May 4, 2012, 141 days after receiving the submission on December 15, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K113689 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2011
Decision Date May 04, 2012
Days to Decision 141 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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