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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K173279
Device Name RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
Applicant
Myco Medical Supplies, Inc.
2015 Production Dr.
Apex,  NC  27539
Applicant Contact Sanjiv Kumar
Correspondent
Smith Associates
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E. J. Smith
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/13/2017
Decision Date 05/14/2018
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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