FDA 510(k) Application Details - K173279

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K173279
Device Name Needle, Hypodermic, Single Lumen
Applicant MYCO Medical Supplies, Inc.
2015 Production Drive
Apex, NC 27539 US
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Contact Sanjiv Kumar
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 10/13/2017
Decision Date 05/14/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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