Imbibe Aspirating XIA Taps

Instrument, Biopsy

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Imbibe Aspirating Xia Taps.

Pre-market Notification Details

Device IDK143546
510k NumberK143546
Device Name:Imbibe Aspirating XIA Taps
ClassificationInstrument, Biopsy
Applicant Stryker Corporation 2 Pearl Court Allendale,  NJ  07401
ContactSoraya King
CorrespondentSoraya King
Stryker Corporation 2 Pearl Court Allendale,  NJ  07401
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-15
Decision Date2015-03-19
Summary:summary

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