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510(k) K853536

Device
VELCRO FISTULA PRESSURE CLAMPS
Applicant
CP MEDICAL
510(k) number
K853536
Product code
KXM  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-17
Date received
1985-08-23
Regulation
876.5820
Classification name
System Accessories, Extracorporeal
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CARL GRODACH
Address
1775 Whittier Ave. Costa Mesa CA US 92627 92627

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KXM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925581BAXTER BIOSTAT 1000 UREA MONITORBaxter Healthcare Corp1995-05-03
K863471COLORADO MEDICAL MODEL PTC 1000Colorado Medical, Inc.1986-10-02
K831402PRESSURE MONITOR & CONTROL UNIT APC-02AParker Hannifin Corp.1983-08-08

Legacy Summary#

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FDA Review#

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