ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN

Accessories, Blood Circuit, Hemodialysis

ERIKA, INC.

The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Negative Pressure Venous Blood Lin.

Pre-market Notification Details

Device IDK822226
510k NumberK822226
Device Name:ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant ERIKA, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-27
Decision Date1982-08-16

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