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510(k) K883490

Device
ACCUFLO UF CONTROL MODULE NO. 74-0100-3
Applicant
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
510(k) number
K883490
Product code
FJB  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-29
Date received
1988-08-16
Regulation
876.5820
Classification name
Detector, Dialysate Level
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DEL DONNA
Address
Two Volvo Dr. Rockleigh NJ US 07647 07647

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FJB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881062CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002Cobe Laboratories, Inc.1988-04-21
K875312UFR DIGITAL RETROFITYankee Intl. Medical Research & Mfg., Ltd.1988-02-19

Legacy Summary#

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FDA Review#

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