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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 K101233
Device Name SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
Applicant
Rexam Pharma
600 Deerfield Pkwy.
Buffalo Grove,  IL  60089
Applicant Contact JEFFREY BURRIS
Correspondent
Rexam Pharma
600 Deerfield Pkwy.
Buffalo Grove,  IL  60089
Correspondent Contact JEFFREY BURRIS
Regulation Number880.5860
Classification Product Code
MEG  
Date Received05/03/2010
Decision Date 02/18/2011
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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