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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K051079
Device Name HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
Applicant
Hospicare, Inc.
275 N. Field Dr.
Dept. 389, Bldg. H2
Lake Forest,  IL  60045
Applicant Contact Yuliya Matlin
Correspondent
Hospicare, Inc.
275 N. Field Dr.
Dept. 389, Bldg. H2
Lake Forest,  IL  60045
Correspondent Contact Yuliya Matlin
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Codes
FPA   FRN  
Date Received04/27/2005
Decision Date 05/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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