FDA.reportPublic FDA data

510(k) K923028

Device
TURKEL PNEUMOTHORAX KIT
Applicant
SYMBIOSIS CORP.
510(k) number
K923028
Product code
GCB  
Decision
Substantially Equivalent (SESE)
Decision date
1992-08-04
Date received
1992-06-23
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
W SMITH
Address
8600 NW 41 St. Miami FL US 33166 33166

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
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#

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

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