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510(k) K212201

Device
PENTAX Medical Auto Leakage Tester SHA-P6
Applicant
PENTAX Of America, Inc.
510(k) number
K212201
Product code
PCV  
Decision
Substantially Equivalent (SESE)
Decision date
2021-10-01
Date received
2021-07-14
Regulation
876.1500
Classification name
Endoscopic Leak Tester
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
William Goeller
Address
3 Paragon Dr., Montvale NJ US 07645 07645

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PCV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123704AUTOMATED ENDOSCOPE LEAK TESTEROlympus Medical Systems Corp.2013-02-04

Legacy Summary#

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FDA Review#

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