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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K912856
Device Name MEDE-FLO I.V. EXTENSION SET
Applicant
Medevice, Inc.
5080 Timberlea Blvd.
Unit 11, Mississauga, Ontario
Canada L4w 4m2,  CA
Applicant Contact RALPH D MANDELL
Correspondent
Medevice, Inc.
5080 Timberlea Blvd.
Unit 11, Mississauga, Ontario
Canada L4w 4m2,  CA
Correspondent Contact RALPH D MANDELL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/28/1991
Decision Date 12/17/1991
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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