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510(k) K162030

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle by Sol-Millennium Medical, Inc. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2016
Date Received
July 22, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Antistick
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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  • K182146 — Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Ca (December 3, 2018)
  • K163073 — Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder (May 19, 2017)
  • K153537 — Sol-M Insulin Syringe, Sol-M TB Syringe (June 17, 2016)

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