SPECIALTY SET MODEL IV7A01

Set, Administration, Intravascular

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Specialty Set Model Iv7a01.

Pre-market Notification Details

Device IDK830891
510k NumberK830891
Device Name:SPECIALTY SET MODEL IV7A01
ClassificationSet, Administration, Intravascular
Applicant VALLEYLAB, INC. 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 Received1983-03-21
Decision Date1983-04-14

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