FDA.report

510(k) K251999

Device
Promogran Prisma™ Collagen Matrix with ORC and Silver
Applicant
Solventum Germany GmbH
510(k) number
K251999
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-13
Date received
2025-06-27
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
Bernadette Rauch
Address
Edisonstrasse 6 Kamen DE 59174 59174

FDA Registration Numbers

Source Documents

510(k) summary PDF

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