NEGATIVE PRESSURE ARTERIAL BLOOD LINE

Instrument, Surgical, Disposable

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 IDK830326
510k NumberK830326
Device Name:NEGATIVE PRESSURE ARTERIAL BLOOD LINE
ClassificationInstrument, Surgical, Disposable
Applicant ERIKA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKDC  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-01
Decision Date1983-02-28

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