The following data is part of a premarket notification filed by Pdo Max, Inc. with the FDA for Pdo Max Suture With Dual Needle.
|Device Name:||PDO Max Suture With Dual Needle|
|Classification||Suture, Surgical, Absorbable, Polydioxanone|
|Applicant||PDO MAX, Inc. 4971 Bear Road Liverpool, NY 13088|
Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738
|CFR Regulation Number||878.4840 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|