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510(k) K974146

Device
PARACENTESIS CATHETER DEVICE
Applicant
ALLEGIANCE HEALTHCARE CORP.
510(k) number
K974146
Product code
GCB  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-28
Date received
1997-11-03
Regulation
878.4200
Classification name
Needle, Catheter
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SHARON ROBBINS
Address
1435 Lake Cook Rd. Deerfield IL US 60015 60015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K854327SUBCUTANEOUS TUNNELING NEEDLES & HANDLESConcord Laboratories, Inc.1985-11-13
K852428MANAN EPIDURAL NEEDLEManan Manufacturing Co., Inc.1985-06-27
K780896NEEDLES, DESIGN CHANGE, IV CATHETERSJelco Laboratories1978-08-23

Legacy Summary#

summary

FDA Review#

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