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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 K924010
Device Name REDINOV PERFUSION SET
Applicant
Bipress, Inc.
5200 Blue Lagoon Dr.
Miami,  FL  33126
Applicant Contact ELLEN R WIDOM
Correspondent
Bipress, Inc.
5200 Blue Lagoon Dr.
Miami,  FL  33126
Correspondent Contact ELLEN R WIDOM
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/10/1992
Decision Date 08/15/1994
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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