PURGE LINE UNIT

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

SURGIKOS, INC.

The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Purge Line Unit.

Pre-market Notification Details

Device IDK790804
510k NumberK790804
Device Name:PURGE LINE UNIT
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant SURGIKOS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-24
Decision Date1979-05-25

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