Cleared Traditional

IN-ROOM AND SHARPSTAR

K941991 · Sage Products, Inc. · General Hospital
Aug 1994
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K941991 is an FDA 510(k) clearance for the IN-ROOM AND SHARPSTAR, a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on August 29, 1994, 126 days after receiving the submission on April 25, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K941991 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1994
Decision Date August 29, 1994
Days to Decision 126 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code MMK — Container, Sharps
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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