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510(k) K854512

Device
TUBING CLAMP CAT#1000-A
Applicant
RAO MEDICAL DEVICES, INC.
510(k) number
K854512
Product code
FKK  
Decision
Substantially Equivalent (SESE)
Decision date
1985-12-02
Date received
1985-11-12
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#

Contact
ROLF A OSCARSSON
Address
P.O. Box 621, 1550 Winchell Drive Hudson OH US 44236 44236

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
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
K802009FLOWCLAMP CAT.#1011 & 1012Pollak (Intl.), Ltd.1980-10-31

Legacy Summary#

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FDA Review#

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