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510(k) K802009

Device
FLOWCLAMP CAT.#1011 & 1012
Applicant
POLLAK (INTL.), LTD.
510(k) number
K802009
Product code
FKK  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-31
Date received
1980-08-20
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
K831689EMPTY DIALYSATE CONTAINERDelmed, Inc.1983-08-11
K822551AMP CAPD UNISPIKE AMINISTRATION SETAmerican Medical Products, Inc.1982-10-13

Legacy Summary#

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FDA Review#

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