K181478 - Roosin Xeroform Petrolatum Dressing (FDA 510(k) Clearance)

K181478 is an FDA 510(k) clearance for the Roosin Xeroform Petrolatum Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Roosin Medical Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on September 13, 2019 after a review of 465 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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