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510(k) K212033

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle by Shandong Zhushi Pharmaceutical Group Co., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2022
Date Received
June 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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