Cleared Traditional

BIOJECTOR SYRINGE SYSTEM

K861687 · Bioject, Inc. · General Hospital
Apr 1987
Decision
356d
Days
Class 2
Risk

About This 510(k) Submission

K861687 is an FDA 510(k) clearance for the BIOJECTOR SYRINGE SYSTEM, a Injector, Fluid, Non-electrically Powered (Class II — Special Controls, product code KZE), submitted by Bioject, Inc. (Portland, US). The FDA issued a Cleared decision on April 23, 1987, 356 days after receiving the submission on May 2, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K861687 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1986
Decision Date April 23, 1987
Days to Decision 356 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KZE — Injector, Fluid, Non-electrically Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5430

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