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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 K170002
Device Name Medline Blood Collection Set
Applicant
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Applicant Contact Matt Clausen
Correspondent
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Correspondent Contact Matt Clausen
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
JKA  
Date Received01/03/2017
Decision Date 09/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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