E-Z LUBRICATING JELLY— 510(k) K041060

Clearance details

Applicant

Chester Labs, Inc.

Product code

Code KMJ

Device class

Class 1

Regulation

21 CFR 880.6375

Advisory panel

General Hospital

Date received

2004-04-23

Decision date

2004-05-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cincinnati, OH, US

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• Z-0984-2017 — Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.Class II·Terminated·MEDLINE IND·20161212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041060.