Cleared Special

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes

K152522 · Ecolab, Inc. · General Hospital
Jan 2016
Decision
134d
Days
Class 1
Risk

About This 510(k) Submission

K152522 is an FDA 510(k) clearance for the ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes, a Warmer, Irrigation Solution (Class I — General Controls, product code LHC), submitted by Ecolab, Inc. (Saint Paul, US). The FDA issued a Cleared decision on January 15, 2016, 134 days after receiving the submission on September 3, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number K152522 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2015
Decision Date January 15, 2016
Days to Decision 134 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHC — Warmer, Irrigation Solution
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5950

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