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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K960921
Device Name CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE
Applicant
Codan Medlon, Inc.
3325 N. Glenoaks Blvd.
Burbank,  CA  91504
Applicant Contact THOMAS J BOUCHARD
Correspondent
Codan Medlon, Inc.
3325 N. Glenoaks Blvd.
Burbank,  CA  91504
Correspondent Contact THOMAS J BOUCHARD
Regulation Number880.5440
Classification Product Code
LHI  
Date Received03/06/1996
Decision Date 04/17/1996
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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