K163529 - ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) (FDA 510(k) Clearance)

K163529 is an FDA 510(k) clearance for the ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing .... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Avery Dennison Corporation (Mentor, US). The FDA issued a Cleared decision on March 29, 2017 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Avery Dennison Corporation devices