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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polypropylene
510(k) Number K171039
Device Name Assut Filbloc Permanent Sutures
Assut Europe S.p.A.
Zona Industriale
Magliano dei Marsi,  IT 67062
Applicant Contact Gloria Aggio
Donawa Lifescience Consulting Srl
Piazza Albania, 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number878.5010
Classification Product Code
Date Received04/06/2017
Decision Date 08/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No