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510(k) K831689

Device
EMPTY DIALYSATE CONTAINER
Applicant
DELMED, INC.
510(k) number
K831689
Product code
FKK  
Decision
Substantially Equivalent (SESE)
Decision date
1983-08-11
Date received
1983-05-24
Regulation
876.4730
Classification name
Clamp, Line
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FKK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K854512TUBING CLAMP CAT#1000-ARao Medical Devices, Inc.1985-12-02
K854517NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SETTravenol Laboratories, S.A.1985-12-02
K844121CLAMP, TUBING, LINEDyn-A-Med Products1984-12-17
K822551AMP CAPD UNISPIKE AMINISTRATION SETAmerican Medical Products, Inc.1982-10-13
K802009FLOWCLAMP CAT.#1011 & 1012Pollak (Intl.), Ltd.1980-10-31

Legacy Summary#

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FDA Review#

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