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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 K871753
Device Name MASTER MEDICAL DEVICE IS I.V. STAT 2
Applicant
The Master Medical Corp.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Applicant Contact JOSEPH R RADZIUS
Correspondent
The Master Medical Corp.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Correspondent Contact JOSEPH R RADZIUS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/05/1987
Decision Date 06/05/1987
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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