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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 K143584
Device Name PGA RESORBA, PGA RESOQUICK, GLYCOLON
Applicant
RESORBA MEDICAL GMBH
AM FLACHMOOOR 16
NUREMBERG,  DE 90475
Applicant Contact KARL JOSEF BECK
Correspondent
RESORBA MEDICAL GMBH
AM FLACHMOOOR 16
NUREMBERG,  DE 90475
Correspondent Contact KARL JOSEF BECK
Regulation Number878.4493
Classification Product Code
GAM  
Date Received12/18/2014
Decision Date 11/02/2015
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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