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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 K942181
Device Name SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116
Applicant
Medtronic Minimed
12744 San Fernando Rd.
Sylmar,  CA  91342
Applicant Contact JOHN LIVINGSTON
Correspondent
Medtronic Minimed
12744 San Fernando Rd.
Sylmar,  CA  91342
Correspondent Contact JOHN LIVINGSTON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/04/1994
Decision Date 07/14/1994
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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