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510(k) K220057

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization by Shinva Ande Healthcare Apparatus Co., Ltd. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2022
Date Received
January 6, 2022
Clearance Type
Traditional
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

Other clearances by Shinva Ande Healthcare Apparatus Co., Ltd.

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  • K202060 — Disposable IV catheter (July 23, 2021)
  • K193657 — Disposable Enteral Feeding Syringe with Enfit Connector (September 12, 2020)
  • K162601 — Infusion Set for Single Use (May 31, 2017)

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