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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K954769
Device Name BIEGLER BW385L BLOOD & INFUSION WARMER
Applicant
Biegler Medical Products, Inc.
7 Iris Ct.
P.O. Box 160
Carlisle, Ontario,  CA L0R 1H0
Applicant Contact MARTIN COSTELLO
Correspondent
Biegler Medical Products, Inc.
7 Iris Ct.
P.O. Box 160
Carlisle, Ontario,  CA L0R 1H0
Correspondent Contact MARTIN COSTELLO
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received10/16/1995
Decision Date 08/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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