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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion, insulin
510(k) Number K993012
Device Name MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311
Applicant
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Applicant Contact JENNIFER LYONS
Correspondent
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Correspondent Contact JENNIFER LYONS
Regulation Number880.5725
Classification Product Code
LZG  
Date Received09/08/1999
Decision Date 11/15/1999
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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