Cleared Traditional

SAFEDWEEL DRESSING CHANGE TRAY

K950438 · Becton Dickinson Vascular Access, Inc. · General Hospital
Mar 1995
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K950438 is an FDA 510(k) clearance for the SAFEDWEEL DRESSING CHANGE TRAY, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on March 15, 1995, 41 days after receiving the submission on February 2, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K950438 FDA.gov
FDA Decision Cleared SESK
Date Received February 02, 1995
Decision Date March 15, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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