Cleared Special

COLONGLIDE LUBRICANT

K141028 · Pediatric Pharmaceuticals, Inc. · General Hospital
Jul 2014
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K141028 is an FDA 510(k) clearance for the COLONGLIDE LUBRICANT, a Lubricant, Patient (Class I — General Controls, product code KMJ), submitted by Pediatric Pharmaceuticals, Inc. (Holmdel, US). The FDA issued a Cleared decision on July 24, 2014, 93 days after receiving the submission on April 22, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K141028 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2014
Decision Date July 24, 2014
Days to Decision 93 days
Submission Type Special
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