Cleared Traditional

IRRIGATION TRAY WITH PISTON SYRINGE

K942221 · Trinity Laboratories, Inc. · General Hospital
Aug 1994
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K942221 is an FDA 510(k) clearance for the IRRIGATION TRAY WITH PISTON SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on August 5, 1994, 91 days after receiving the submission on May 6, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K942221 FDA.gov
FDA Decision Cleared SESK
Date Received May 06, 1994
Decision Date August 05, 1994
Days to Decision 91 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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