Cleared Traditional

BLOOD NEEDLE HOLDER

K873569 · Sage Products, Inc. · General Hospital
Nov 1987
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K873569 is an FDA 510(k) clearance for the BLOOD NEEDLE HOLDER, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Sage Products, Inc. (Cary, US). The FDA issued a Cleared decision on November 3, 1987, 62 days after receiving the submission on September 2, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K873569 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1987
Decision Date November 03, 1987
Days to Decision 62 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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