Cleared Traditional

PHLEBOTOMY SHARPS DISPOSAL CONTAINERS

K943660 · Sage Products, Inc. · General Hospital
Mar 1995
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K943660 is an FDA 510(k) clearance for the PHLEBOTOMY SHARPS DISPOSAL CONTAINERS, 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 March 22, 1995, 238 days after receiving the submission on July 27, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K943660 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1994
Decision Date March 22, 1995
Days to Decision 238 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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