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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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