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510(k) K926066

Device
BION MUMPS-G ANTIBODY TEST SYSTEM
Applicant
BION ENT., LTD.
510(k) number
K926066
Product code
CAR  
Decision
Substantially Equivalent (SESE)
Decision date
1993-06-15
Date received
1992-12-01
Regulation
880.2460
Classification name
Monitor, Spinal-fluid Pressure, Electrically Powered
Medical specialty
General Hospital
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EDWARD NOWAKOWSKI
Address
674 Busse Hwy. Park Ridge IL US 60068 60068

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CAR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920740EPISENSOR PLUSIndustrias Palex C/O Dma Med-Chem Corp.1994-03-07
K915577IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICEImpra, Inc.1992-03-11

Legacy Summary#

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FDA Review#

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