Topseal Hemostatic Dressing, Model 11150

by Radi Medical Systems AB 510(k)

Active United States

510(k) K033291

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK033291	Date17 Mar 2004Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K033291
FDA Product Code: QSY

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

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