ERIKA NEGATIVE PRESSURE VENOUS BL SETS

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 Negative Pressure Venous Bl Sets.

Pre-market Notification Details

Device IDK792054
510k NumberK792054
Device Name:ERIKA NEGATIVE PRESSURE VENOUS BL SETS
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant ERIKA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-10-15
Decision Date1979-12-06

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