Cleared Traditional

SPAN / AID SYRINGE

K854255 · Span-America Medical Systems, Inc. · General Hospital
Nov 1985
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K854255 is an FDA 510(k) clearance for the SPAN / AID SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on November 12, 1985, 21 days after receiving the submission on October 22, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K854255 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1985
Decision Date November 12, 1985
Days to Decision 21 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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