Cleared Traditional

GENOTROPIN MIXER

K954337 · Pharmacia, Inc. · General Hospital
Nov 1995
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K954337 is an FDA 510(k) clearance for the GENOTROPIN MIXER, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Pharmacia, Inc. (Columbus, US). The FDA issued a Cleared decision on November 13, 1995, 56 days after receiving the submission on September 18, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K954337 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1995
Decision Date November 13, 1995
Days to Decision 56 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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