Cleared Traditional

COLONGLIDE(R) LUBRICANT

K131617 · Pediatric Pharmaceuticals, Inc. · General Hospital
Oct 2013
Decision
122d
Days
Class 1
Risk

About This 510(k) Submission

K131617 is an FDA 510(k) clearance for the COLONGLIDE(R) 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 October 3, 2013, 122 days after receiving the submission on June 3, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K131617 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2013
Decision Date October 03, 2013
Days to Decision 122 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