TOURNIQUET/LATEX TOURNIQUET

Tourniquet, Nonpneumatic

PRIMELINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Primeline Industries, Inc. with the FDA for Tourniquet/latex Tourniquet.

Pre-market Notification Details

Device IDK830467
510k NumberK830467
Device Name:TOURNIQUET/LATEX TOURNIQUET
ClassificationTourniquet, Nonpneumatic
Applicant PRIMELINE INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGAX  
CFR Regulation Number878.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-15
Decision Date1983-03-31

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