PLASTIC TUBING ADAPTERS 5-IN-1-

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

HARVARD LABORATORIES

The following data is part of a premarket notification filed by Harvard Laboratories with the FDA for Plastic Tubing Adapters 5-in-1-.

Pre-market Notification Details

Device IDK800880
510k NumberK800880
Device Name:PLASTIC TUBING ADAPTERS 5-IN-1-
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant HARVARD LABORATORIES 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 Received1980-04-17
Decision Date1980-05-14

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