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510(k) K924549

Device
TRI-MED QUICK-STEP(TM) RECTAL TUBE
Applicant
TRI-MED SPECIALTIES, INC.
510(k) number
K924549
Product code
GBT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-10
Date received
1992-09-09
Regulation
876.5980
Classification name
Catheter, Rectal
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
LARRY SCOTT
Address
P.O. Box 23306 Overland Park KS US 66223 66223

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K941391INFLATABLE RETENTION CUFF SPECULUMInnovatec Medical Corp.1994-10-20
K890466SIGMOID TONOMITORTonometrics, Inc.1989-04-21

Legacy Summary#

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FDA Review#

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