Cleared Traditional

DRUG RECONSTITUTION FILTER DEVICE

K941020 · Gelman Sciences, Inc. · General Hospital
Aug 1994
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K941020 is an FDA 510(k) clearance for the DRUG RECONSTITUTION FILTER DEVICE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on August 10, 1994, 160 days after receiving the submission on March 3, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K941020 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1994
Decision Date August 10, 1994
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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