FDA.reportPublic FDA data

510(k) K901716

Device
KLEIN CONNECTOR(TM)
Applicant
JEFF KLEIN SURGICAL, INC.
510(k) number
K901716
Product code
GCE  
Decision
Substantially Equivalent (SESE)
Decision date
1990-05-11
Date received
1990-04-13
Regulation
878.4200
Classification name
Adaptor, Catheter
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JACQUELINE KLEIN
Address
P.O. Box 1269 San Clemente CA US 92674 92674

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K901715KLEIN CORK(TM)Jeff Klein Surgical, Inc.1990-05-11
K855039MEDIFLEX INJECTION CAPMediflex Intl.1986-01-24
K801680BETA-CAP II ADAPTERQuinton, Inc.1980-08-04

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