Cleared Traditional

AQUALUBE(TM)

K864556 · Parker Laboratories, Inc. · General Hospital
Dec 1986
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K864556 is an FDA 510(k) clearance for the AQUALUBE(TM), a Lubricant, Patient (Class I — General Controls, product code KMJ), submitted by Parker Laboratories, Inc. (Orange, US). The FDA issued a Cleared decision on December 1, 1986, 12 days after receiving the submission on November 19, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K864556 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1986
Decision Date December 01, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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