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510(k) K896731

Device
OXYGEN CATHETERS
Applicant
UNOPLAST A/S
510(k) number
K896731
Product code
BZB  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-30
Date received
1989-11-30
Regulation
868.5350
Classification name
Catheter, Nasal, Oxygen
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ERIK ANDERSEN
Address
Dk-3390 Hundested Denmark DK

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BZB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843466PHARMA-PLAST OXYGEN CATHETERZimmar Consulting , Ltd.1984-11-19
K833351DEMAND OXYGEN CONTROLLERHealthdyne, Inc.1984-03-19
K830984OXYGEN CATHETERSMedovations, Inc.1983-05-18
K820370NASAL OXYGEN CATHETERAmerican Pharmaseal Div. Ahsc1982-04-16
K800506OXYGEN CATHETERMedi-Craft , Ltd.1980-03-25
K791273CONPHAR OXYGEN CATHETER-STERILEConphar, Inc.1979-07-24
K790057CATHETER, OXYGENMedline Industries, Inc.1979-02-05

Legacy Summary#

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FDA Review#

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