Cleared Traditional

NHMC IRRIGATION TRAY

K962670 · National Healthcare Mfg. Corp. · Gastroenterology & Urology
Aug 1996
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K962670 is an FDA 510(k) clearance for the NHMC IRRIGATION TRAY, a System, Irrigation, Urological (Class II — Special Controls, product code LJH), submitted by National Healthcare Mfg. Corp. (Winnipeg, Mb, CA). The FDA issued a Cleared decision on August 14, 1996, 36 days after receiving the submission on July 9, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K962670 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1996
Decision Date August 14, 1996
Days to Decision 36 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code LJH — System, Irrigation, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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