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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 K141664
Device Name SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION
Applicant
REXAM HEALTHCARE
20 AVENUE DE LA GARE
LA VERPILLIERE,  FR 38292
Applicant Contact BEATRICE GRAND DEMARS
Correspondent
REXAM HEALTHCARE
20 AVENUE DE LA GARE
LA VERPILLIERE,  FR 38292
Correspondent Contact BEATRICE GRAND DEMARS
Regulation Number880.5860
Classification Product Code
MEG  
Date Received06/23/2014
Decision Date 10/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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