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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 K232372
Device Name Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
Applicant
Peters Surgical
10 Cordage Park Cir. #100
Plymouth,  MA  02360
Applicant Contact Ellen Henke-Knupp
Correspondent
Peter Surgical
Immeuble Aurelium, 1 Cours De 1'Ile Seguin
Boulogne-Billancourt,  FR 92100
Correspondent Contact Marie Compagnon Riobé
Regulation Number878.4493
Classification Product Code
GAM  
Date Received08/08/2023
Decision Date 07/12/2024
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
Predetermined Change
Control Plan Authorized		 No
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