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510(k) K951198

Device
FE-34TH, FIBER ESOPHAGOSCOPE
Applicant
PENTAX PRECISION INSTRUMENT CORP.
510(k) number
K951198
Product code
GCL  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-30
Date received
1995-03-16
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAUL SILVA
Address
3117 Commerce Pkwy. Miramar FL US 33025 33025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K9345105,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREADPhx Technologies Corp.1994-02-17
K922086BARD BIOPSY FORCEPSC.R. Bard, Inc.1992-10-30

Legacy Summary#

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FDA Review#

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