Cleared Traditional

SKIN SCRUB TRAY

K944881 · Clinical Resources, Inc. · General Hospital
Dec 1994
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K944881 is an FDA 510(k) clearance for the SKIN SCRUB TRAY, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on December 27, 1994, 85 days after receiving the submission on October 3, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K944881 FDA.gov
FDA Decision Cleared SEKD
Date Received October 03, 1994
Decision Date December 27, 1994
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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