ORTHOPEDIC SOFT GOODS

Sling, Arm

ABCO DEALERS, INC.

The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Orthopedic Soft Goods.

Pre-market Notification Details

Device IDK820590
510k NumberK820590
Device Name:ORTHOPEDIC SOFT GOODS
ClassificationSling, Arm
Applicant ABCO DEALERS, 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 Received1982-03-04
Decision Date1982-03-26

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