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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 K974163
Device Name MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
Applicant
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Applicant Contact DON SELVEY
Correspondent
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Correspondent Contact DON SELVEY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/05/1997
Decision Date 02/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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