FDA.report

510(k) K254073

Device
StatSeal Disc
Applicant
Merit Medical Systems, Inc.
510(k) number
K254073
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-13
Date received
2025-12-18
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Alexander Bohorquez
Address
1600 W. Merit Pkwy. South Jordan UT US 84095 84095

FDA Registration Numbers

Source Documents

510(k) summary PDF

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