Cleared Traditional

GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10

K962329 · Global Medical Prods, Inc. · General Hospital
Sep 1996
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K962329 is an FDA 510(k) clearance for the GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Global Medical Prods, Inc. (Woodbury, US). The FDA issued a Cleared decision on September 12, 1996, 87 days after receiving the submission on June 17, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K962329 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1996
Decision Date September 12, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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