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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K251999
Device Name Promogran Prisma™ Collagen Matrix with ORC and Silver
Applicant
Solventum Germany GmbH
Edisonstrasse 6
Kamen,  DE 59174
Applicant Contact Bernadette Rauch
Correspondent
Solventum Germany GmbH
Edisonstrasse 6
Kamen,  DE 59174
Correspondent Contact Bernadette Rauch
Classification Product Code
FRO  
Subsequent Product Code
OMP  
Date Received06/27/2025
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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