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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Device Disinfectant
510(k) Number K080579
Device Name EFFECTIV (TM) CAP
Applicant
Hospira, Inc.
275 N. Field Dr.
Lake Forest,  IL  60045
Applicant Contact REBECCA ANDERSEN
Correspondent
Hospira, Inc.
275 N. Field Dr.
Lake Forest,  IL  60045
Correspondent Contact REBECCA ANDERSEN
Regulation Number880.5440
Classification Product Code
QBP  
Date Received03/03/2008
Decision Date 09/11/2008
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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