Cleared Traditional

GAINOR MEDICAL SYRINGE

K844306 · Gainor Medical · General Hospital
Nov 1984
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K844306 is an FDA 510(k) clearance for the GAINOR MEDICAL SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Gainor Medical. The FDA issued a Cleared decision on November 30, 1984, 24 days after receiving the submission on November 6, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K844306 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1984
Decision Date November 30, 1984
Days to Decision 24 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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