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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 K030149
Device Name MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9
Applicant
Avail Medical Products, Inc.
1900 Carnegie Ave.
Santa Ana,  CA  92705
Applicant Contact CARROLL COUNCILMAN
Correspondent
Avail Medical Products, Inc.
1900 Carnegie Ave.
Santa Ana,  CA  92705
Correspondent Contact CARROLL COUNCILMAN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/15/2003
Decision Date 03/20/2003
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
Recalls CDRH Recalls
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