Cleared Traditional

SHARPS COLLECTION CONTAINER - SAF-T-SHELL

K982029 · American Medical Mfg., Inc. · General Hospital
Apr 1999
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K982029 is an FDA 510(k) clearance for the SHARPS COLLECTION CONTAINER - SAF-T-SHELL, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by American Medical Mfg., Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 6, 1999, 301 days after receiving the submission on June 9, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K982029 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1998
Decision Date April 06, 1999
Days to Decision 301 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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