FDA.reportPublic FDA data

510(k) K961167

Device
MEDCARE TRACHEOSTOMY CARE TRAY
Applicant
MEDCARE MEDICAL GROUP, INC.
510(k) number
K961167
Product code
LRQ  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1996-07-02
Date received
1996-03-25
Regulation
510(k) Premarket Notification
Classification name
Tracheostomy And Nasal Suctioning Kit
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CRAIG J BELL
Address
234 Old Homestead Hwy. East Swanzey NH US 03446 03446

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LRQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963720TRACHEOSTOMY KITGrand Medical Products1996-11-27
K952925READY NURSE SYSTEM (RNS) TRACH CARE KITContour Fabricators of Florida, Inc.1995-07-12
K950851GENT-L-KARE TRACHEOSTOMY TRAYSPremium Plastics, Inc.1995-06-21
K871692TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1Automatic Liquid Packaging, Inc.1987-06-01
K862663TRACHEOSTOMY CARE TRAYWelmed Systems, Inc.1986-07-30

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases