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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Holder, Syringe
510(k) Number K063180
Device Name ISECURE SYRINGE CARTRIDGE HOLDER
Applicant
Hospira, Inc.
275 N. Field Dr., Bldg. H-2
Dept. 389
Lake Forest,  IL  60045
Applicant Contact DIANE RENNPFERD
Correspondent
Hospira, Inc.
275 N. Field Dr., Bldg. H-2
Dept. 389
Lake Forest,  IL  60045
Correspondent Contact DIANE RENNPFERD
Regulation Number890.5050
Classification Product Code
IQG  
Subsequent Product Code
FMF  
Date Received10/19/2006
Decision Date 12/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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