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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K032247
Device Name U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE
Applicant
U.S. Technologies, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact ROSINA ROBINSION
Correspondent
U.S. Technologies, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact ROSINA ROBINSION
Regulation Number880.5860
Classification Product Code
MEG  
Date Received07/22/2003
Decision Date 09/30/2003
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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