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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, Elastomeric
510(k) Number K993832
Device Name AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
Applicant
Tandem Medical, Inc.
15910 Bernardo Center Dr.
San Diego,  CA  92127
Applicant Contact ALBERT MISAJON
Correspondent
Tandem Medical, Inc.
15910 Bernardo Center Dr.
San Diego,  CA  92127
Correspondent Contact ALBERT MISAJON
Regulation Number880.5725
Classification Product Code
MEB  
Date Received11/12/1999
Decision Date 02/09/2000
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
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