K813365 - MULTIPLE BANDAGE OR DRESSING (FDA 510(k) Clearance)

K813365 is an FDA 510(k) clearance for the MULTIPLE BANDAGE OR DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Cederroth, Inc. USA (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982 after a review of 66 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cederroth, Inc. USA devices