A.C. SPLINT

Sling, Arm

DANEK MEDICAL, INC.

The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for A.c. Splint.

Pre-market Notification Details

Device IDK823810
510k NumberK823810
Device Name:A.C. SPLINT
ClassificationSling, Arm
Applicant DANEK MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeILI  
CFR Regulation Number890.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-17
Decision Date1983-01-14

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