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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 K142097
Device Name SELEC-3 I.V.ADMINISTRATION SET
Applicant
BIOMEDIX, INC.
3895 WEST VERNAL PIKE
Blmgtn,  IN  47404
Applicant Contact MYRA J BENDER
Correspondent
BIOMEDIX, INC.
3895 WEST VERNAL PIKE
Blmgtn,  IN  47404
Correspondent Contact MYRA J BENDER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/01/2014
Decision Date 08/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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