KIRSCHNER WIRE

Rod, Fixation, Intramedullary And Accessories

AMERICAN SAFETY EQUIPMENT CORP.

The following data is part of a premarket notification filed by American Safety Equipment Corp. with the FDA for Kirschner Wire.

Pre-market Notification Details

Device IDK801010
510k NumberK801010
Device Name:KIRSCHNER WIRE
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant AMERICAN SAFETY EQUIPMENT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-28
Decision Date1980-05-20

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