Lubricating Jelly— 510(k) K142473

Substantially Equivalent

Sion Biotext Medical , Ltd.

FDA 510(k) clearance K142473 for Lubricating Jelly, Substantially Equivalent on 2015-04-13. Applicant: Sion Biotext Medical , Ltd.. Device class: 1.

Clearance details

Applicant: Sion Biotext Medical , Ltd.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 2014-09-03
Decision date: 2015-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Upper Galilee, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMJ

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K131617 — COLONGLIDE(R) LUBRICANT2013-10-03
K121390 — LUBE JELLY SURINGE2012-08-10
K113689 — DUKAL LUBRICATING JELLY2012-05-04
K112110 — STERILE LUBRICATING JELLY2012-04-10

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