Cleared Traditional

MEDCARE TRACHEOSTOMY CARE TRAY

K961167 · Medcare Medical Group, Inc. · General & Plastic Surgery

Jul 1996

Decision

99d

Days

Class 1

Risk

About This 510(k) Submission

K961167 is an FDA 510(k) clearance for the MEDCARE TRACHEOSTOMY CARE TRAY, a Tracheostomy And Nasal Suctioning Kit (Class I — General Controls, product code LRQ), submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on July 2, 1996, 99 days after receiving the submission on March 25, 1996. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K961167 FDA.gov
FDA Decision	Cleared SESK
Date Received	March 25, 1996
Decision Date	July 02, 1996
Days to Decision	99 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

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.