SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL— 510(k) K073684

Name: FDA 510(k) clearance K073684
Creator: U.S. Food and Drug Administration
Published: 2008-05-22

Substantially Equivalent

Sheffield Industries, Div. of Faria , Ltd.

FDA 510(k) clearance K073684 for SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL, Substantially Equivalent on 2008-05-22. Applicant: Sheffield Industries, Div. of Faria , Ltd.. Device class: 1.

Clearance details

Applicant: Sheffield Industries, Div. of Faria , Ltd.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 2007-12-28
Decision date: 2008-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New London, CT, US

Download summary PDF View on FDA.gov ↗

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K113689 — DUKAL LUBRICATING JELLY2012-05-04

Recalls naming K073684

K-number listed on FDA's recall record

Z-1953-2015 — Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.Class II·Terminated·Sheffield Pharmaceuticals, LLC·20150427

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073684.

Data sourced from openFDA. This site is unofficial and independent of the FDA.