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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scale, Patient
510(k) Number K864327
Device Name MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP
Applicant
Medtronic Minimed
12744 San Fernando Rd.
Sylmar,  CA  91342
Applicant Contact WILLIAM DUFFELL
Correspondent
Medtronic Minimed
12744 San Fernando Rd.
Sylmar,  CA  91342
Correspondent Contact WILLIAM DUFFELL
Regulation Number880.2720
Classification Product Code
FRW  
Date Received11/04/1986
Decision Date 02/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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