Cleared Traditional

MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0

K882506 · Span-America Medical Systems, Inc. · General Hospital
Sep 1988
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K882506 is an FDA 510(k) clearance for the MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0, 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 September 9, 1988, 92 days after receiving the submission on June 9, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K882506 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1988
Decision Date September 09, 1988
Days to Decision 92 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