NEGATIVE PRESSURE ARTERIAL BLOOD LINE

Accessories, Blood Circuit, Hemodialysis

ERIKA, INC.

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

Pre-market Notification Details

Device IDK822796
510k NumberK822796
Device Name:NEGATIVE PRESSURE ARTERIAL BLOOD LINE
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 Received1982-09-16
Decision Date1982-10-18

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