Collagen Wound Dressing

by Dalim Tissen Co., Ltd. South Korea 510(k)

510(k) K112580 Product code KGN

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK112580	Date1 Jun 2012Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K112580
FDA Product Code: KGN

Device Class: U
Advisory Committee: Unknown
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K112580 24 fields · synced 22 Oct 2026