Cleared Traditional

AUTOPEN

K895890 · Ulster Scientific, Inc. · General Hospital
Feb 1990
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K895890 is an FDA 510(k) clearance for the AUTOPEN, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on February 16, 1990, 134 days after receiving the submission on October 5, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K895890 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1989
Decision Date February 16, 1990
Days to Decision 134 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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