K143335 - Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) (FDA 510(k) Clearance)

K143335 is an FDA 510(k) clearance for the Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dress.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Roosin Medical Devices Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on June 1, 2015 after a review of 193 days - an extended review 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: 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 Roosin Medical Devices Co., Ltd. devices