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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 K201996
Device Name Monocryl Plus Antibacterial Suture
Applicant
Ethicon Inc.
Route 22 West, P.O. Box 151
Somerville,  NJ  08876
Applicant Contact Joice Pappan
Correspondent
Ethicon Inc.
Route 22 West, P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact Joice Pappan
Regulation Number878.4493
Classification Product Code
GAM  
Date Received07/20/2020
Decision Date 12/21/2020
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
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