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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 K991112
Device Name SAGE CONTRAST MANAGEMENT SYSTEM
Applicant
Sage Laboratories, Inc.
5408 Interstate Dr.
Shreveport,  LA  71109
Applicant Contact DAVID CHEN
Correspondent
Sage Laboratories, Inc.
5408 Interstate Dr.
Shreveport,  LA  71109
Correspondent Contact DAVID CHEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/01/1999
Decision Date 09/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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