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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 K882594
Device Name THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM
Applicant
OMNI-FLOW, INC.
317 NEW BOSTON ST.
WILMINGTON,  MA  01887
Applicant Contact MARGARET M CURTIN
Correspondent
OMNI-FLOW, INC.
317 NEW BOSTON ST.
WILMINGTON,  MA  01887
Correspondent Contact MARGARET M CURTIN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/24/1988
Decision Date 09/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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