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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K902810
Device Name STERILE I.V. START KIT
Applicant
ORION LIFE SYSTEMS, INC.
124 MESSNER DR.
WHEELING,  IL  60090
Applicant Contact JOHN L LAEMMAR
Correspondent
ORION LIFE SYSTEMS, INC.
124 MESSNER DR.
WHEELING,  IL  60090
Correspondent Contact JOHN L LAEMMAR
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/27/1990
Decision Date 11/13/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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