Cleared Traditional

HYPOSERMIC NEEDLES

K813545 · Optical Micro Systems, Inc. · General Hospital
Jan 1982
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K813545 is an FDA 510(k) clearance for the HYPOSERMIC NEEDLES, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Optical Micro Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1982, 22 days after receiving the submission on December 21, 1981. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K813545 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1981
Decision Date January 12, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

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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