Cleared Traditional

LACERATION TRAY

K955658 · Transidyne General Corp. · General Hospital
Jan 1996
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K955658 is an FDA 510(k) clearance for the LACERATION TRAY, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on January 25, 1996, 44 days after receiving the submission on December 12, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K955658 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1995
Decision Date January 25, 1996
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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