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510(k) K950851

Device
GENT-L-KARE TRACHEOSTOMY TRAYS
Applicant
PREMIUM PLASTICS, INC.
510(k) number
K950851
Product code
LRQ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-21
Date received
1995-02-24
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
GARY GARBIN
Address
465 W. Cermak Rd. Chicago IL US 60616 60616

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
K961167MEDCARE TRACHEOSTOMY CARE TRAYMedcare Medical Group, Inc.1996-07-02
K952925READY NURSE SYSTEM (RNS) TRACH CARE KITContour Fabricators of Florida, Inc.1995-07-12
K871692TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1Automatic Liquid Packaging, Inc.1987-06-01
K862663TRACHEOSTOMY CARE TRAYWelmed Systems, Inc.1986-07-30

Legacy Summary#

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FDA Review#

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