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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 K850506
Device Name CORRECT FLO INTRAVASCULAR ADMINISTRATION SET
Applicant
Biomedical Dynamics, Inc.
3800 Multifoods Tower
33 S. Sixth St.
Minneapolis,  MN  55402
Applicant Contact POINDEXTER, JACOBSON
Correspondent
Biomedical Dynamics, Inc.
3800 Multifoods Tower
33 S. Sixth St.
Minneapolis,  MN  55402
Correspondent Contact POINDEXTER, JACOBSON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/08/1985
Decision Date 04/01/1985
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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