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510(k) K921993

Device
ELS AUTOMATIC TUBING CLAMP SYSTEM
Applicant
ROCKY MOUNTAIN RESEARCH, INC.
510(k) number
K921993
Product code
FIG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-05
Date received
1992-04-28
Regulation
876.5820
Classification name
Clamp, Tubing, Blood, Automatic
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THERESE DAVY
Address
2715 E. 3300 S. Salt Lake City UT US 84109 84109

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FIG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093915DEKA TAC DEVICEDeka Research & Development Corp.2011-08-23
K914459AUTOMATIC TUBING CLAMPRocky Mountain Research, Inc.1992-06-24
K770535C-DAK 3500Cordis Corp.1977-04-15

Legacy Summary#

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FDA Review#

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