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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 K990801
Device Name MINIMED 508 INSULIN PUMP
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 Number880.5725
Classification Product Code
LZG  
Date Received03/10/1999
Decision Date 06/08/1999
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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