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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sharps Needle Destruction Device
510(k) Number K202073
Device Name NeedleSmart Professional (NS Pro)
Applicant
Needlesmart Limited
Suite 2b, Stanley Grange Business Park, Ormskirk Rd.
Knowsley, Prescot,  GB L34 5NB
Applicant Contact Tom Baker
Correspondent
Needlesmart Limited
Suite 2b, Stanley Grange Business Park, Ormskirk Rd.
Knowsley, Prescot,  GB L34 5NB
Correspondent Contact Tom Baker
Regulation Number880.6210
Classification Product Code
MTV  
Date Received07/27/2020
Decision Date 03/25/2021
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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