FDA 510(k) Application Details - K242291

Device Classification Name

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510(K) Number K242291
Device Name SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (L
Applicant Sol-Millennium Medical Inc.
311 S Wacker Drive Suite 4100
Chicago, IL 60606 US
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Contact Kalia Manu
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Regulation Number

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Classification Product Code QNQ
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Date Received 08/02/2024
Decision Date 11/20/2024
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

FDA Source Information for K242291


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