SECONDARY I.V. TUBING SETS

Set, Administration, Intravascular

HARVARD LABORATORIES

The following data is part of a premarket notification filed by Harvard Laboratories with the FDA for Secondary I.v. Tubing Sets.

Pre-market Notification Details

Device IDK800878
510k NumberK800878
Device Name:SECONDARY I.V. TUBING SETS
ClassificationSet, Administration, Intravascular
Applicant HARVARD LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-17
Decision Date1980-06-17

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