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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K021767
Device Name ASSUFIL
Applicant
ASSUT EUROPE S.P.A.
10147 UMBERLAND PLACE
BOCA RATON,  FL  33428
Applicant Contact LUCIO IMPROTA
Correspondent
ASSUT EUROPE S.P.A.
10147 UMBERLAND PLACE
BOCA RATON,  FL  33428
Correspondent Contact LUCIO IMPROTA
Regulation Number878.4493
Classification Product Code
GAM  
Date Received05/29/2002
Decision Date 11/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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