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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 K852616
Device Name MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE
Applicant
Medical Hospital Equipment
236 Third Ave., Suite A
Chula Vista,  CA  92010
Applicant Contact VINCENT A MARUCA
Correspondent
Medical Hospital Equipment
236 Third Ave., Suite A
Chula Vista,  CA  92010
Correspondent Contact VINCENT A MARUCA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/12/1985
Decision Date 04/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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