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510(k) K875312

Device
UFR DIGITAL RETROFIT
Applicant
YANKEE INTL. MEDICAL RESEARCH & MFG., LTD.
510(k) number
K875312
Product code
FJB  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-19
Date received
1987-12-29
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
D. W BROUS
Address
P.O. Box 151 Manchese NH US 03105 03105

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
K883490ACCUFLO UF CONTROL MODULE NO. 74-0100-3National Medical Care, Medical Products Div., Inc.1988-09-29
K881062CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002Cobe Laboratories, Inc.1988-04-21

Legacy Summary#

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FDA Review#

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