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510(k) K844889

Device
MENSINK-GOOSEN CATHETER
Applicant
GOOSEN ENTERPRISES, INC.
510(k) number
K844889
Product code
GBP  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-18
Date received
1984-12-17
Regulation
878.4200
Classification name
Catheter, Multiple Lumen
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
P.O. Box 10 Goldenrod FL US 32733 32733

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K821220MULTILUMEN INTRAVENOUS INFUSION CATHETERClincal Instruments Corp.1982-07-09
K820446CATHETER, MULTIPLE LUMENDlp, Inc.1982-03-11

Legacy Summary#

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FDA Review#

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