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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 K233265
Device Name Monotime and Optime R
Applicant
Peters Surgical
10 Cordage Park Circle
Plymouth,  MA  02360
Applicant Contact Ellen Henke Knupp
Correspondent
Peters Surgical
Immeuble Aurelium, 1 Course De 1'Lle Seguim
Boulogne-Billancourt,  FR 92100
Correspondent Contact Vikram Verma
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/29/2023
Decision Date 10/11/2024
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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