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510(k) K854327

Device
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
Applicant
CONCORD LABORATORIES, INC.
510(k) number
K854327
Product code
GCB  
Decision
Substantially Equivalent (SESE)
Decision date
1985-11-13
Date received
1985-10-28
Regulation
878.4200
Classification name
Needle, Catheter
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT WHEELER
Address
Kit St. Keene NH US 03431 03431

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150800Valved Safety Centesis CatheterB.Braun Medical, Inc.2015-11-12
K974146PARACENTESIS CATHETER DEVICEAllegiance Healthcare Corp.1998-01-28
K930568ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.1993-07-22
K923028TURKEL PNEUMOTHORAX KITSymbiosis Corp.1992-08-04
K900374ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.1990-04-20
K852428MANAN EPIDURAL NEEDLEManan Manufacturing Co., Inc.1985-06-27
K780896NEEDLES, DESIGN CHANGE, IV CATHETERSJelco Laboratories1978-08-23

Legacy Summary#

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FDA Review#

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