ERIKA HEPARIN INFUSION ADAPTOR

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

ERIKA, INC.

The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Heparin Infusion Adaptor.

Pre-market Notification Details

Device IDK810824
510k NumberK810824
Device Name:ERIKA HEPARIN INFUSION ADAPTOR
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant ERIKA, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-24
Decision Date1981-04-17

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