Cleared Traditional

USI AUTOJECT INSULIN SYRINGE

K864761 · Ulster Scientific, Inc. · General Hospital
Dec 1986
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K864761 is an FDA 510(k) clearance for the USI AUTOJECT INSULIN SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on December 16, 1986, 11 days after receiving the submission on December 5, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K864761 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 1986
Decision Date December 16, 1986
Days to Decision 11 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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