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FDA 510(k) Application Details - K242291
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
Kalia Manu
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QNQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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