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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K251874
Device Name PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
Applicant
Pureway Compliance, Inc.
2717 Commercial Center Blvd. Cinco Rancy
Suite 200
Katy,  TX  77494
Applicant Contact Jeffrey Miglicco
Correspondent
Pureway Compliance, Inc.
2717 Commercial Center Blvd.
Suite 200
Katy,  TX  77494
Correspondent Contact Jeffrey Miglicco
Regulation Number880.5570
Classification Product Code
MMK  
Date Received06/18/2025
Decision Date 10/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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