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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 K210135
Device Name PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
Applicant
3M Healthcare Business Group
3m Centre, Cain Rd.
Berkshire, Bracknell Forest,  GB RG12 8HT,
Applicant Contact Margaret Marsh
Correspondent
3M Healthcare Business Group
3m Centre, Cain Rd.
Berkshire, Bracknell Forest,  GB RG12 8HT,
Correspondent Contact Margaret Marsh
Classification Product Code
FRO  
Date Received01/19/2021
Decision Date 02/24/2022
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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