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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 K883653
Device Name EP-100 INFUSION PUMP
Applicant
Stereotactic Medical Systems, Inc.
2801 So. 1935 W.
West Valley City,  UT  84119
Applicant Contact GLEN S PUTNAM
Correspondent
Stereotactic Medical Systems, Inc.
2801 So. 1935 W.
West Valley City,  UT  84119
Correspondent Contact GLEN S PUTNAM
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/26/1988
Decision Date 11/01/1988
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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