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510(k) K855039

Device
MEDIFLEX INJECTION CAP
Applicant
MEDIFLEX INTL.
510(k) number
K855039
Product code
GCE  
Decision
Substantially Equivalent (SESE)
Decision date
1986-01-24
Date received
1985-12-17
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#

Address
30 Chapin Rd. Box 2007 Pine Brook NJ US 07058 07058

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
K901716KLEIN CONNECTOR(TM)Jeff Klein Surgical, Inc.1990-05-11
K801680BETA-CAP II ADAPTERQuinton, Inc.1980-08-04

Legacy Summary#

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FDA Review#

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