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510(k) K911577

Device
HYPOTRANS MODEL 750
Applicant
MARTIN MCLANE MEDICAL
510(k) number
K911577
Product code
KDK  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-08
Date received
1991-04-08
Regulation
876.5880
Classification name
Container, Transport, Kidney
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DEBRA MCQUILLEN
Address
7317 El Cajon Blvd. Suite 201 La Mesa CA US 91941 91941

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K053169RM3 RENAL PRESERVATION SYSTEMWaters Instruments, Inc.2006-01-17
K801899KEITHLEY LYMPHOCYTE DEPLETION CARTKeithley Development Co.1980-09-26

Legacy Summary#

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FDA Review#

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