Cleared Traditional

AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G

K870742 · Span-America Medical Systems, Inc. · General Hospital
Jun 1987
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K870742 is an FDA 510(k) clearance for the AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G, 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 June 5, 1987, 100 days after receiving the submission on February 25, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K870742 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1987
Decision Date June 05, 1987
Days to Decision 100 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