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510(k) K914887

Device
ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT
Applicant
MALLINCKRODT MEDICAL
510(k) number
K914887
Product code
FRQ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-08
Date received
1991-10-30
Regulation
876.5980
Classification name
Tube, Levine
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEFFERY W BIGGERS
Address
675 Mcdonnell Blvd. P.O. Box 5840 St Louis MO US 63134 63134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FRQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914530ICAN GT DRAINAGE BAGIcn Pharmaceuticals, Inc.1991-12-18
K802007PEDIWET=GUAZE IMPREGNATED WITH PETROLPollak (Intl.), Ltd.1980-09-26

Legacy Summary#

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FDA Review#

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