Cleared Traditional

READY NURSE SYSTEM (RNS) TRACH CARE KIT

K952925 · Contour Fabricators of Florida, Inc. · General & Plastic Surgery
Jul 1995
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K952925 is an FDA 510(k) clearance for the READY NURSE SYSTEM (RNS) TRACH CARE KIT, a Tracheostomy And Nasal Suctioning Kit (Class I — General Controls, product code LRQ), submitted by Contour Fabricators of Florida, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on July 12, 1995, 16 days after receiving the submission on June 26, 1995. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K952925 FDA.gov
FDA Decision Cleared SESK
Date Received June 26, 1995
Decision Date July 12, 1995
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code LRQ — Tracheostomy And Nasal Suctioning Kit
Device Class Class I — General Controls
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.