Cleared Traditional

RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY

K955689 · Contour Fabricators of Florida, Inc. · Cardiovascular
May 1996
Decision
153d
Days
Class 1
Risk

About This 510(k) Submission

K955689 is an FDA 510(k) clearance for the RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY, a Instruments, Surgical, Cardiovascular (Class I — General Controls, product code DWS), submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on May 15, 1996, 153 days after receiving the submission on December 14, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4500.

Submission Details

510(k) Number K955689 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1995
Decision Date May 15, 1996
Days to Decision 153 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DWS — Instruments, Surgical, Cardiovascular
Device Class Class I — General Controls
CFR Regulation 21 CFR 870.4500

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