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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K212380
Device Name PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
Applicant
Ethicon, Inc.
1000 Route 202
Raritan,  NJ  08869
Applicant Contact Marife Sevek
Correspondent
Ethicon, Inc.
1000 Route 202
Raritan,  NJ  08869
Correspondent Contact Marife Sevek
Regulation Number878.4840
Classification Product Code
NEW  
Date Received08/02/2021
Decision Date 02/22/2022
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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