Cleared Traditional

PRIMARY SURGICAL DRESSING TRAY

K922041 · Transidyne General Corp. · General Hospital
Nov 1992
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K922041 is an FDA 510(k) clearance for the PRIMARY SURGICAL DRESSING TRAY, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on November 6, 1992, 189 days after receiving the submission on May 1, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K922041 FDA.gov
FDA Decision Cleared SEKD
Date Received May 01, 1992
Decision Date November 06, 1992
Days to Decision 189 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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