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510(k) K240961

Disposable Pen Injector Assembly by Wuxi Nest Biotechnology Co., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2024
Date Received
April 8, 2024
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

Other clearances by Wuxi Nest Biotechnology Co., Ltd.

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