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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 K210871
Device Name PDO Max Suture with Dual Needle
Applicant
Pdo Max, Inc.
4971 Bear Rd.
Liverpool,  NY  13088
Applicant Contact Giovanna McCarthy
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number878.4840
Classification Product Code
NEW  
Date Received03/24/2021
Decision Date 12/17/2021
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
Predetermined Change
Control Plan Authorized		 No
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