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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 K941595
Device Name MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5
Applicant
Microject, Inc.
390 Wakara Way,
Suite 44
Salt Lake City,  UT  84108
Applicant Contact LARRY RIGBY
Correspondent
Microject, Inc.
390 Wakara Way,
Suite 44
Salt Lake City,  UT  84108
Correspondent Contact LARRY RIGBY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/01/1994
Decision Date 12/19/1994
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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