PENTAX Medical Auto Leakage Tester SHA-P6

Endoscopic Leak Tester

PENTAX Of America, Inc.

The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Auto Leakage Tester Sha-p6.

Pre-market Notification Details

Device IDK212201
510k NumberK212201
Device Name:PENTAX Medical Auto Leakage Tester SHA-P6
ClassificationEndoscopic Leak Tester
Applicant PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
ContactWilliam Goeller
CorrespondentWilliam Goeller
PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
Product CodePCV  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-14
Decision Date2021-10-01

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