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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K970479
Device Name MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
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 Number880.6920
Classification Product Code
KZH  
Date Received02/07/1997
Decision Date 03/31/1997
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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