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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
510(k) Number K922670
Device Name THE MINIMED MODEL 404-SP AND 504-S
Applicant
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Applicant Contact RAY MCCARTNEY
Correspondent
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Correspondent Contact RAY MCCARTNEY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/13/1992
Decision Date 09/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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