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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 K861209
Device Name STREAM-SWITCH MANIFOLD
Applicant
Intelligent Medicine, Inc.
253 Adams St.
Denver,  CO  80206
Applicant Contact DAVID C HOWSON
Correspondent
Intelligent Medicine, Inc.
253 Adams St.
Denver,  CO  80206
Correspondent Contact DAVID C HOWSON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/31/1986
Decision Date 06/23/1986
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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