Cleared Traditional

K961502 - LUBRICATING JELLY, LOW VISCOSITY
(FDA 510(k) Clearance)

K961502 · Span-America Medical Systems, Inc. · General Hospital
Jul 1996
Decision
90d
Days
Class 1
Risk

K961502 is an FDA 510(k) clearance for the LUBRICATING JELLY, LOW VISCOSITY, a Lubricant, Patient (Class I — General Controls, product code KMJ), submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on July 18, 1996, 90 days after receiving the submission on April 19, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K961502 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1996
Decision Date July 18, 1996
Days to Decision 90 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