THE ARTHROFILE

Rasp

DYONICS, INC.

The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for The Arthrofile.

Pre-market Notification Details

Device IDK812506
510k NumberK812506
Device Name:THE ARTHROFILE
ClassificationRasp
Applicant DYONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHTR  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-01
Decision Date1981-09-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.