Cleared Traditional

LUBE JELLY SURINGE

K121390 · Nurse Assist, Inc. · General Hospital
Aug 2012
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K121390 is an FDA 510(k) clearance for the LUBE JELLY SURINGE, a Lubricant, Patient (Class I — General Controls, product code KMJ), submitted by Nurse Assist, Inc. (Haltom City, US). The FDA issued a Cleared decision on August 10, 2012, 93 days after receiving the submission on May 9, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K121390 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2012
Decision Date August 10, 2012
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KMJ — Lubricant, Patient
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6375