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510(k) K211484

Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles by Shinva Ande Healthcare Apparatus Co., Ltd. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2022
Date Received
May 12, 2021
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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  • K193657 — Disposable Enteral Feeding Syringe with Enfit Connector (September 12, 2020)
  • K162601 — Infusion Set for Single Use (May 31, 2017)

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  • K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle) (November 23, 2022)
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