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510(k) K934510

Device
5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD
Applicant
PHX TECHNOLOGIES CORP.
510(k) number
K934510
Product code
GCL  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-17
Date received
1993-09-14
Regulation
876.1500
Classification name
Esophagoscope, General & Plastic Surgery
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
JAMES F CHAPEL
Address
Post Office Box 1059 Lewisville TX US 75067 75067

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951197FE-24X, FIBER ESOPHAGOSCOPEPentax Precision Instrument Corp.1995-05-30
K951198FE-34TH, FIBER ESOPHAGOSCOPEPentax Precision Instrument Corp.1995-05-30
K922086BARD BIOPSY FORCEPSC.R. Bard, Inc.1992-10-30

Legacy Summary#

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FDA Review#

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