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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 K190245
Device Name PDS Barbed Suture, PDO MAXX Threads
4971 Bear Road
Liverpool,  NY  13088
Applicant Contact Giovanna McCarthy
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number878.4840
Classification Product Code
Date Received02/06/2019
Decision Date 06/04/2019
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